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Journal of Osteology and Biomaterials The official journal of the BioCRA and SENAME Societies

BioCRA Biomaterial Clinical and histological Research Association President Giampiero Massei Deputy-president Alberto Rebaudi Scientific Director Paolo Trisi Secretary Teocrito Carlesi Editor in-chief Paolo Trisi, DDS PhD Scientfic director BioCRA, Pescara, Italy Associate Editor Gilberto Sammartino, MD DDS University of Naples Federico II, Naples, Italy Francesco Carinci, MD DMD University of Ferrara, Ferrara, Italy Assistant Editor Teocrito Carlesi, DDS Secretary BioCRA, Chieti, Italy Managing Editor Renato C. Barbacane, MD University G. d’Annunzio, Chieti, Italy

www.osteobiom.com

SENAME The South European, North African, Middle Eastern Implantology and Modern Dentistry Society President Gilberto Sammartino Deputy-president Ahamed M. Osman Scientific Director Paolo Trisi Secretary Arzu Demircioglu

Editorial Board

Roberto Abundo, Turin, Italy Mario Aimetti, Turin, Italy Moshe Ayalon, Hadera, Israel Luigi Ambrosio, Naples, Italy Massimo Balsamo, Thiene, Italy Francesco Benazzo, Pavia, Italy Ermanno Bonucci, Roma, Italy Mauro Bovi, Rome, Italy Maria Luisa Brandi, Firenze, Italy Paul W. Brown, Pennsylvania, USA Ranieri Cancedda, Genova, Italy Saverio Capodiferro, Bari, Italy Sergio Caputi, Chieti, Italy Chih-Hwa Chen, Keelung, Taiwan Joseph Choukroun, Nice, France Gabriela Ciapetti, Bologna, Italy Giuseppe Corrente, Turin, Italy Massimo Del Fabbro, Milan, Italy Marco Esposito, Manchester, UK Antonello Falco, Pescara, Italy Gianfranco Favia, Bari, Italy Paolo Filipponi, Umbertide, Italy Pier Maria Fornasari, Bologna, Italy Bruno Frediani, Siena, Italy Sergio Gandolfo, Turin, Italy David Garber, Atlanta, USA Zhimon Jacobson, Boston, USA Jack T Krauser, Boca Raton, USA Richard J. Lazzara, West Palm Beach, USA Lorenzo Lo Muzio, Foggia, Italy Gastone Marotti, Modena, Italy Christian T. Makary, Beirut, Lebanon

Gideon Mann, Jerusalem, Israel Ivan Martin, Basel, Switzerland Milena Mastrogiacomo, Genoa, Italy Anthony McGrath, Santmore, UK Alvaro Ordonez, Coral Gables, USA Zeev Ormianer, Tel-Aviv, Israel Carla Palumbo, Modena, Italy Sandro Palla, Zurich, Switzerland Ady Palti, Kraichtal, Germany Michele Paolantonio, Chieti, Italy Giorgio Perfetti, Chieti, Italy Adriano Piattelli, Chieti, Italy Domenique P. Pioletti, Lausanne, Switzerland Sergio Rosini, Pisa, Italy Ugo Ripamonti, Johannesburg, South Africa Henry Salama, Atlanta, USA Maurice Salama, Atlanta, USA Lucia Savarino, Bologna, Italy Arnaud Scherberich, Basel, Switzerland Nicola Marco Sforza, Bologna, Italy Christian FJ Stappert, New York, USA Marius Steigman, Neckargemünd, Germany Hiroshi Takayanagi, Tokyo, Japan Dennis Tarnow, San Francisco, USA Tiziano Testori, Milan, Italy Anna Teti, L’Aquila, Italy Oriana Trubiani, Chieti, Italy Alexander Veis, Thessaloniki, Greece Raffaele Volpi, Rome, Italy Giovanni Vozzi, Pisa, Italy Hom-Lay Wang, Michigan, USA Xuejun Wen, South Carolina, USA

Journal of Osteology and Biomaterials (ISSN: 2036-6795; On-line version ISSN 2036-6809) is the official journal of the Biomaterial Clinical and histological Research Association (BioCRA). The Journal is published three times a year, one volume per year, by TRIDENT APS, Via Silvio Pellico 68, 65123 Pescara, Italy. Copyright ©2011 by TRIDENT APS. All rights reserved. No part of this journal may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information and retrieval system, without permission in writing from the publisher. The views expressed herein are those of the publisher or the Biomaterial Clinical and histological Research Association (BioCRA). Information included herein is not professional advice and is not intended to replace the judgment of a practitioner with respect to particular patients, procedures, or practices. To the extent permissible under applicable laws, the publisher and BioCRA disclaim responsibility for any injury and/ or damage to person or property as result of any actual or alleged libellous statements, infringement of intellectual property or other proprietary or privacy rights, or from the use or operation of any ideas, instructions, procedure, products, or methods contained in the material therein. The publisher assumes no responsibility for unsolicited manuscript.

Volume 2 - Number 1 - 2011

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Journal of Osteology and Biomaterials

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Journal of Osteology and Biomaterials The official journal of the BioCRA and SENAME Societies

contents Review articles

Clinical and histological outcomes of bone augmentation with allograft to enable dental implant placement: a systematic review Marco Clementini, Pasquale Rizzo, Corrado Agrestini, Alberto Barlattani

Original articles

Ultrasonic vs. drill osteotomy. A clinical and histologic study in the sheep mandible.

Bone tissue integration with immediately loaded implants in aesthetic zone. A four year prospective clinical study

Paolo Trisi, Teocrito Carlesi, Marco Colagiovanni, Antonello Falco, Mauro Bovi, Giorgio Perfetti

Luca Di Alberti, Federica Donnini, Michele Camerino, Claudio Di Alberti, Lorenzo Lo Muzio

hydroxyapatite custom made cranioplasty: 43 Porous the 3D design techniques prostheses in 21 patients Corrado Iaccarino, Vania Ramponi, Reza Ghadirpour, Francesco Carinci, Franco Servadei

55 69

Skeletal height estimation from regression analysis of clavicular lengths in Northwest Indian cadavers of Chandigarh region Jagmahender Singh, Raj Kamal Pathak

Technical note

Sinus Physiolift: a new technique for a less invasive great sinus augmentation with crestal approach Rosario Sentineri, Giorgio Dagnino Volume 2 - Number 1 - 2011

BioCRA

Review

Clinical and histological outcomes of bone augmentation with allograft to enable dental implant placement: a systematic review. Marco Clementini1*, Pasquale Rizzo1, Corrado Agrestini1, Alberto Barlattani1

Aim The objectives of this systematic review were to assess the success rate of grafts and implants placed in sites augmented by means of allograft, and to elaborate a histological and histomorphometric analysis of allograft for different bone augmentation techniques (alveolar ridge augmentation, socket preservation, sinus elevation). Materials and methods An electronic search was provided to identify studies on bone allograft, including works with a mean follow-up time of at least 6 months after functional loading. Two different analysis (clinical and histological) were performed including papers with clearly defined outcome measures. Results The search provided 227 titles, which underwent a strict text analysis. Implant survival at the augmented sites (irrespective of the procedures used) varied from 89% to 100%, while the success rate of the grafts varied from 68.18% to 100% for a period between 6 and 72 months; new bone formation (range: 28% - 48%) and presence of residual graft particles (range: 7.29% 52.4%) were observed at a mean time of 6 months. Conclusions For the concept of bone augmentation with allograft to enable dental implant placement, there are clinical and histological data supporting its potential use. Given the confined number of investigators using this bone substitute and the low number of patient treated reported in the literature, the generalizability of this approach is limited at this time. (J Osteol Biomat 2011;1:7-19)

Key words:dental implants, bone grafting, homologous bone, allograft

Clinica Odontostomatologica Dipartimento di Odontoiatria, UniversitĂ Tor Vergata, Roma

Corresponding author: *Prof. Marco Clementini Clinica Odontostomatologica Dipartimento di Odontoiatria UniversitĂ Tor Vergata Roma Via Monpellier 2, 00169 Roma Mob. +39 338 8378866 mclementini@hotmail.com

INTRODUCTION The introduction of osseointegration and advances in biomaterials and surgical techniques have contributed to increased application of dental implants in the restoration of partial and completely edentulous patients1,2. Often, in these patients, it is observed soft and hard tissue defects resulting from a variety of causes, such as infection, trauma, and above all tooth loss3,4. These conditions create an anatomically less favourable foundation for ideal implant placement and in recent years, the development and refinement of bone regeneration techniques has contributed to solve such situations and increase the use of fixed prosthetic rehabilitation5. In fact, these procedures enable to obtain adequate bone support for implants with a proper implant-crown ratio and an esthetic and functional prosthesis6. During recent years, various augmentation techniques and materials have been studied and described7,8,9: the search for an ideal bone substitute constitutes a common challenge in oral surgery, and it aims to find the best material which could guarantee both, valid properties and less costs for patients10. In most cases, autogenous grafts, from extra11-or intra12-oral sites, or various bone substitutes13,14 have been used as grafting

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Clementini M. et al.

material. Although autogenous bone grafts appear to be the ideal material, there are some disadvantages to consider, such as the need in most cases of general anesthesia and a second surgical site leading to increased postoperative morbidity and treatment costs15. In fact many of these patients are old and have diseases that might complicate these procedures, which are factors to take into consideration. Therefore, the use of bone substitutes might be a solution for these patients: the advantages to avoid a second surgical site and consequent less morbidity contributed to the choice of an alternative to autogenous bone for maxillofacial reconstruction procedures16. Homologous bone is a tissue from a donor who belongs to the same species but is not genetically related to the recipient17. Bone allografts are obtained form cadavers or prosthetic hip replacement procedures, processed and stored in bone banks. Many advantages are related to this bone substitute: availability, absence of the necessity of a donor site in the patient, decreased anesthesia and surgery time, decreased blood loss, and fewer complications18. However, some disadvantages are related to tissues coming from another individual: the medical history must be thoroughly checked to eliminate donors with a history of infections, malignant neoplasms, degenerative bone diseases, hepatites B or C, sexually transmitted diseases, autoimmune defiency, and other problems that affect the quality of the bone and the health of the recipient19. Even if osteogenesis is not a proprieties for allografts20, bone formation is dued to the osteoinductive effect of

Journal of Osteology and Biomaterials

surrounding undifferentiated mesenchymal cells, present in the soft tissue over the graft as the blood vessels grow into the graft, or to the osteoconduction phenomenon, in which the host bone resorbs the material and grows into the scaffold21. Among humans allogenic bone graft is available in large quantities at a relative low cost in three different main types: fresh-frozen, freeze-dried (lyophilized), and demineralised freeze-dried bone22. For patients with severely atrophied alveolar crest in the maxilla and when autogenous bone graft and general anesthesia are not an option, this treatment modality could be an alternative23. The aim of this review is to state, in a systematic way, if bone allograft could represent a valid alternative to autograft in the rehabilitation of atrophic maxillary. Focused questions Study 1 “What are the clinical outcomes of allografts in terms of graft success/survival and implant success/ survival, in comparison with other bone substitutes and implant placed in sites augmented with other bone substitutes?” Study 2 “What are the histological outcomes of allografts in terms of percentage of new bone formation/ residual graft particles, in comparison with other bone substitutes?” MATERIALS AND METHODS Search strategy A literature search was performed by using MEDLINE and EMBASE database.

The following keywords were used: (dental implants OR osseointegrated implants OR oral implants) AND (dried fresh frozen human bone allografts OR fresh frozen human bone allografts OR allograft OR homologous bone) AND (bone grafts OR bone grafting OR grafts OR autogenous bone OR heterologous bone OR bone substitutes OR xenograft OR autograft OR alloplastic OR sinus augmentation OR sinus elevation OR sinus elevation OR guided bone regeneration OR guided tissue regeneration) Study selection Studies eligible for inclusion in the review had to be randomized trials, controlled clinical trials, cohort studies, case control studies, cross-sectional surveys or case series with a follow up of at least 4-month. Inclusion criteria: • studies on human subjects • publications in English or Italian and with available full-texts • studies reporting on success rate of reconstructive technique • studies reporting on success rate of implants placed in grafted sites • studies reporting on survival rate of implants placed in grafted sites • a mean follow-up time of at least 4 months after loading • studies on smokers were included • patients with bone atrophy caused by tooth extraction/loss • studies with a minimum of ten patients Exclusion criteria: • not reporting on homologous bone as bone substitute • language restriction or not available full-texts • studies on animals

Clementini M. et al.

• not clearly defined outcomes • periimplant bone defects filling • patients with bone atrophy caused by trauma or cancer • studies reporting on intraossoeus periodontal defect treatment • no distinction of survival/success rate data between various grafting techniques • combination of different graft materials in the same site

evant to reveal all the features of the works, such as setting, number and characteristics of participants, type of intervention, type of outcome measure and results.

Steps in search 1. Searching for relevant studies The first stage of this work was the search for relevant studies which was conducted by two different reviewers (M.C, P.R) using two different database (MEDLINE and EMBASE). Different keywords and a combination of them was used to include all related works present in literature at the time of the search. 2. Titles screening Second stage was the title screening in which all titles resulting from the first stage analysis were carefully read and evaluated. Into this stage a first selection of papers was made, excluding studies with irrelevant titles and including the others. 3. Abstracts evaluation Into the third stage a strict analysis of the abstracts could excluded studies not presenting in matherials and methods clearly inclusion criteria. 4. Full-text examination Full-text examination was the most important stage of our analysis: the articles were strictly evaluated and it was definitively established if they were matching the inclusion criteria. Every part of the papers were considered rel-

Types of outcome measures Study 1 Implant survival rate Implant survival rate is one of the most commonly used outcomes. Van Steenberghe et al. (1999) defined as survival rate ‘‘the proportion of implants still in place in a specific time, even if they do not have any function’’24. We considered this clinical outcome for all works which did not clearly specify implant success criteria.

Types of intervention The following types of intervention were included: socket preservation, sinus lift, guided bone regeneration (GBR technique) and onlay bone grafts.

Implant success rate Implant success rate is another commonly used outcome. An implant can be considered successful if according to the following criteria, previously defined by Albrektsson et al. (1986) and adapted by Buser and co-workers (1997) as well as Karoussis et al. (2004)25,26,27: 1. Absence of mobility (Buser et al. 1990)26. 2. Absence of persistent subjective complaints (pain, foreign body sensation and/or dysaesthesia) (Buser et al. 1990)26. 3. Absence of recurrent peri-implant infection with suppuration (Buser et al. 1990) 26.

4. Absence of a continuous radiolucency around the implant (Buser et al. 1990)26. 5. No pocket probing depth (PPD) >5mm (Mombelli & Lang 1994,Bragger et al. 2001) 28,29. 6. No PPD > or =5mm and bleeding on probing (BOP) (Mombelli & Lang 1994) 28. 7. During the first year, a 1.5mm of vertical bone resorption was accepted. After the first year of loading, the annual vertical bone loss should not exceed 0.2mm (mesially or distally) (Albrektsson et al. 1986, Albrektsson & Isidor 1994) 25. Grafting success rate A bone graft is considered successful when it is osseointegrated and the amount of bone after grafting is considered enough for implant placement; a CT evaluation should show that scaffolds are well integrated and adapted to the cortical bone30. Histologic examination of biopsy samples evaluates the percentage of residual graft particles and the presence of new vital bone and uninflammed connective tissue around them31. Study 2 New bone formation The new bone formation was evaluated through a histomorphometric examination that, for every specimen, showed whether the particles of bone grafting were surrounded by newly formed bone, in which percentage and what kind of contact was established between new bone and residual graft particles.

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Clementini M. et al.

Residual graft particles Through a histomorphometric analysis, residual graft particles could be identified and distinguished from newly formed bone and connective tissue. This analysis allows us to identify the graft particles which were not substituted from new bone and were still present in the site at the time of biopsy. RESULTS Study 1 The search provided 227 potentially relevant articles. The first stage (titles screening) excluded 159 titles because not considered relevant or because reporting on different outcomes or different pathologies which did not match inclusion criteria; the second stage (ab-

stract analysis) excluded 17 abstract because of different reasons: 7 papers reported studies on animals, 3 had language restrictions, 2 for not available full-texts and 5 works because not satisfying the inclusion follow-up criteria; the third stage (full-text examination) revealed that 13 papers could be included in our review while 38 articles were excluded because of the following reasons: inadequate number of patients, treatment due to trauma or cancer, periimplant bone defects filling, not clearly defined outcomes, combination of different materials in the same site, not reporting on homologous bone grafting outcome.

Included studies A total of thirteen studies, published from 1994 to 2008, were included in the systematic review. In eight out of thirteen works success/ survival rate of 338 implants placed in grafted sites was evaluated; in three papers only the grafting success rate was analysed. The surgical procedures of the included studies were: socket preservation, sinus lift, GBR technique and onlay bone grafts. (Table 1). Patients intervention and characteristics A total of 382 patients, between 16 and 81 years, were treated. 50 patients underwent a GBR techniques, 24 a socket preservation procedure, 253 an onlay bone graft process and 43 both sinus

Table 1.

Study

No. Of patients

Mean Age

Gomes46

N.R.

Onlay bone graft and Sinus augmentation

Not specified allograft

Stacchi34

60,2 (41-69)

Sinus augmentation

FFB

Fagan32

N.R.

Onlay bone graft

FDBA

Filho Cerruti30

65 (45-75)

Onlay bone graft

Not specified allograft

Keith35

47,2 (16-76)

Onlay bone graft

FDBA

Implant Survival

Fugazzotto33

N.R. (36-68)

Onlay bone graft

DFDBA

Implant Success Grafting Success

Iasella40

51,5 (28-76)

Socket preservation

FDBA

Grafting success

Feuille31

N.R. (23-65)

Onlay bone graft

FDBA

Grafting success

Block36

N.R.

Onlay bone graft

FDBA

Implant Survival Grafting Success

Simon45

N.R.

GBR

Kassolis37

N.R. (25-72)

Simion38

51 (34-66)

Onlay bone graft and Sinus augmentation

Gher39

55,2 (26-81)

Augmentation procedure Bone substitute

DFDBA

Outcome measures Grafting Success Implant Survival Grafting Success Implant Success Grafting Success Grafting Success

Grafting success

FDBA

Implant Survival Grafting Success

GBR

DFDBA

Implant Survival

GBR

DFDBA

Implant Survival Grafting Success

FFB: fresh-frozen bone, FDBA: freeze-dried mineralized bone allograft, DFDBA: demineralized freeze-dried bone allograft, GBR: guided bone regeneration, N.R.: not reported

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Clementini M. et al.

augmentation and onlay bone graft procedure. Augmentation techniques The included works reported results about the following surgical procedures: one work40 (Iasella et al. 2003) reported data on a socket preservation procedure, three papers38,39,45 (Simion et al., Simon et al, Gher et al.) executed a GBR technique, one article34 (Stacchi et al.) a sinus elevation procedure, six papers30,31,32,33,35,36 (Fagan et al., Filho Cerruti et al., Keith et al., Fugazzotto et al., Feuille et al., Blocks et al.) onlay bone graft technique and two arti-

cles37,46 reported data on a both sinus elevation and onlay bone graft procedures (Gomes et al., Kassolis et al.). Graft materials The types of allograft used in the included studies were: fresh-frozen bone (FFB) in one study34 (Stacchi et al. 2008), freeze-dried mineralized bone (FDB) in six papers31,32,35,36,37,40 (Fagan et al. 2008, Keith et al. 2006, Iasella et al. 2003, Feuille et al. 2003, Blocks et al. 2002, Kassolis et al. 2000) and demineralised freeze-dried bone allograft (DFDBA) in 4 articles32,38,39,45 (Fugazzotto et al. 2006, Simon et al. 2000, Simion

et al. 1998, Gher et al. 1994). Two papers30,46 did not specified which type of allograft was used (Gomes et al. 2008 and Filho Cerruti et al. 2007). Grafting success rate Grafting success rate was evaluated in twelve articles and it was assessed after a 4 to 12 months follow-up period. In all articles they showed a range of success rate from 68,18% to 100%. A total of 374 sites were considered, and bone augmentations were considered successful when they provided adequate alveolar bone for implant placement. Eight papers showed a 100%

Table 2.

Study Gomes46 Stacchi34

Bone substitutes

No. Of sites

Not specified 28 (Upper Jaw) allograft FFB 10 (Upper Jaw)

Follow-up (grafting)

Success Success Survival Follow-up rate No. of implants Rate rate (implants) (grafting) (Implants) (Implants)

8 months

85,7

5 months

100

Fagan32

FDBA

37 (Upper Jaw)

4-7 months

Filho Cerruti30

Not specified allograft

32 (Upper Jaw)

8 months

Keith35

FDBA

Fugazzotto33

DFDBA

Iasella40

FDBA

Feuille31

FDBA

Block36

FDBA

Simon45

N.R.

22 (5 m.) 1 year A. 12 100,00 (Immediate) 6-12 m. B. 25 (Delayed)

N.R.

100%

97,30%

94,70

N.R.

93,00

90 (4-6 m.)

13-24

N.R.

99%

82 (Upper and 12 months Lower Jaw) 83 (Upper Jaw) 12,4 months 12 (Upper and 4-6 months Lower Jaw) 12 (Not 6 months Specified) 22 (Upper and 4 months Lower Jaw)

100,00 83 (Immediate) 12,4 m.

100%

100,00

N.R.

100,00

N.R.

100,00

22 (4 m.)

Â N.R.

N.R.

100%

DFDBA

19 (Upper and Lower Jaw)

4 months

100,00

N.R.

Kassolis37

FDBA

15 (Upper Jaw)

5 months

100,00

36 (5 m.)

12 m.

N.R.

89%

Gher39

DFDBA

22 (Upper and Lower Jaw)

6 months

68,18

22 (Immediate)

6 m.

N.R.

100%

Simion38

DFDBA

22 (Upper and Lower Jaw)

26 (N.R.)

7-11 m.

N.R.

100%

FFB: fresh-frozen bone, FDBA: freeze-dried mineralized bone allograft, DFDBA: demineralized freeze-dried bone allograft, GBR: guided bone regeneration, N.R.: not reported

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Clementini M. et al.

Table 3.

Study

No. Of Mean Age patients 58,74 (47-78)

Augmentation procedure

Bone substitute

Outcome measure

Sinus augmentation

FDBA

Sinus augmentation

FFB

Onlay bone graft

Not specified

Interaction bone/graft

Onlay bone graft

FDBA

Interaction bone/graft

New bone formation Residual graft particles Interaction bone/graft New bone formation Interaction bone/graft

Kolerman42

Stacchi34

Filho Cerruti30

Keith35

Scarano41

61 (52-68)

Sinus augmentation

DFDBA

Cammarck43

N.R (21-76)

Sinus augmentation

A. DFDBA B. FDBA

Iasella40

51,5 (28-76)

Socket preservation

FDBA

Feuille31

N.R (23-65)

Onlay bone graft

FDBA

Kassolis37

Sinus augmentation Onlay bone graft

FDBA

Interaction bone/graft

Simion38

N.R. (25-72) 51 (34-66)

GBR

DFDBA

Interaction bone/graft

Becker44

N.R

Socket preservation

A. FDBA B. DFDBA

Interaction bone/graft

60,2 (41-69) 65 (45-75) 47,2 (16-76)

4New bone formation Residual graft particles Interaction bone/graft New bone formation Residual graft particles Interaction bone/graft New bone formation Residual graft particles Interaction bone/graft New bone formation Residual graft particles Interaction bone/graft

FDBA: freeze-dried mineralized bone allograft, DFDBA: demineralized freeze-dried bone allograft, GBR: guided bone regeneration

success rate31,32,33,34,36,37,40,45, while other three works gave a range of 85,7%94,7%30,35,46 (Gomes et al 2008, Filho Cerruti et al 2007, Keith et al 2006); one study provided a 68,18% rate39 (Gher et al 1994), where a complete resolution of the osseous defects was shown only on 15 out of 22 sites; in this paper DFDBA was used to augment bone volume. (Table 2) Implant success rate For the concept of implant success rate, only two works32,33 (Fagan et al 2008, Fugazzotto et al. 2006) were considered because in these studies

Journal of Osteology and Biomaterials

implants were judged successful only if according to the criteria of Albrektsson et al. They obtained a 97,30% of success after a 6-12 months follow-up for 12 implants placed immediately after onlay bone grafting and for 25 placed delayed (Fagan et al.)32 and a 100% of success after a mean follow-up of 12,4 months (Fugazzotto et al.)33 for 83 implants placed immediately after onlay bone grafting. (Table 2) Implant survival rate Seven works were considered eligible for this outcome, for a total of 268 implants. The time of placement varied

from 4 to 6 months after grafting or, in one study (Gher et al. 1994)39 implants were inserted immediately after bone grafting; one paper (Simion et al. 1998)38 didnâ&#x20AC;&#x2122;t specify the time of implant placement. Anyway the analysed studies gave an implant survival rate that varied from 89% to 100%34-39. (Table 2) Study 2 The electronic search gave 227 items which, in the first stage, underwent a title screening that provided 35 articles. The most of articles were excluded because not referring on histological and histomorphometric analysis of

Clementini M. et al.

homologous bone. The second stage included the abstract evaluation and implied one exclusion because the article had not clearly defined outcomes and other three exclusions because the full-text could not be obtained. The third stage, the full-text examination, provided 11 studies which could be considered fulfilling the inclusion criteria and twenty papers were excluded because of the following reasons: insufficient number of patients, not clearly defined outcomes, combination of different materials in the same sites. Included studies A total of eleven articles were included in this systematic review. Papers were published between 1996 and 2008. All the works evaluated histologically the bone grafts and their behaviour, while only six papers referred on the percentage of new bone and only five studies on the percentage of residual graft particles. (Table 3) Patients number The review included works in which a total of 327 patients, between 16 and 78 years were treated. 20 patients underwent a GBR techniques, 39 a socket preservation procedure, 115 an onlay bone graft process, 15 both sinus augmentation and onlay bone graft procedure and 138 sinus augmentation Augmentation techniques The eleven articles included in this systematic review analysed homologous bone grafting in different surgical procedures: four papers34,42,43,44 reported data on sinus augmentation procedures (Kolerman et al., Stacchi et al., Scarano et al., Cammarck et al.) one38

on a GBR technique (Simion et al.), two40,44 papers on socket preservation (Iasella et al., Becker et al.) three30,31,35 reported data on onlay bone grafts (Filho Cerruti et al., Keith et al., Feuille et al.) and one37 paper on sinus augmentations and onlay bone grafts procedures (Kassolis et al.). Graft materials The graft materials used in the works included in this systematic review were: FDB (Freeze-dried bone) in seven articles (Kolerman et al. 2008, Keith et al. 2006, Cammarck et al. 2005, Iasella et al. 2003, Feuille et al. 2003, Kassolis et al. 2000, Becker et al. 1996), FFB (Fresh frozen bone) in one34 work (Stacchi et al. 2008) and DFDB (Demineralized freeze-dried bone) in four38,41,43,44 papers (Scarano et al. 2006, Cammarck 2005, Simion et al. 1998, Becker et al. 1996). New bone formation Six articles provided as outcome measure the percentage of new bone present at the time of biopsy. The reentry ranged from 5 to 9 months in five papers, and in one out of six (Cammarck et al. 2005)43 the biopsy was obtained from 4 to 36 months because its aim was to evaluate the different quantity of new bone present at different times of the healing. The percentage ranged from 28 to 48,15 in a total of 172 patients. Using FDBA and a membrane barrier for a ridge preservation treatment, Iasella et al.40 reported a percentage of new bone of 28%. A 29% and 29,1% of new bone was provided for two sinus augmentations using DFDBA41 (Scarano et al. 2006) and FDBA42 (Kolerman et al. 2008); Cam-

marck et al.43 reported a percentage of 41,74 for DFDBA and of 41,89 for FDBA; the higher mean percentage was obtained from Stacchi et al.35 in ten sinus elevations with FFB, and it was 48,15. (Table 4) Residual graft particles Five papers analysed the residual graft particles present at the moment of biopsy: the period varied from 4 months to 36 months. The percentage of graft particles varied from 7,29 to 52,4 in a total of 162 patients which underwent bone augmentations procedures. The lower percentage of residual graft particles was given by Cammarck et al.43 in sinus lift and ridge augmentation: 7,29 for FDBA and 8,49 for DFDBA. Kolerman et al.42 gave a 19% of residual particles of FDBA in 19 sinus elevations. A 34% for DFDBA41 (Scarano et al. 2006) and a 37% for FDBA40 (Iasella et al. 2003) were obtained for two sinus lifts. The higher percentage of residual graft particles was provided by Feuille et al.31 in his study, in which ten patient were treated by means of ridge augmentation: it was 52,40% of FDBA particles at 6 months. (Table 4) Interaction between new bone and graft residual All eleven works reported on the interaction of residual graft particles and new bone formation: most of wo rks30,31,34,35,37,38,40,41,42,43,44 reported a close contact between graft particles and new bone, with the presence of osteoblasts around graft particles after a minimum of 4 month re-entry. Stacchi et al.35 reported on FFB particles fused and not distinguishible with active osteogenesis process around them after

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Clementini M. et al.

Table 4.

Study

% of Time of Residual Biopsy graft (follow-up) particles

% of New New bone-Residual graft Inflammation Bone contact (histological evaluation)

Other findings

Kolerman42

9 m.

29,1

Close contact

Presence of osteoblasts

Stacchi34

5 m.

N.R.

48,15

Fused and not distinguishible

Active ostogenesis was observed

Filho Cerruti30

8 m.

N.R.

Well integrated and adapted

Presence of osteoblasts

Keith35

6 m.

N.R.

Surrounded and focally merged

Scarano41

6 m.

Cammarck43

6-36 m.

A. 8,49 B. 7,29

A.41,74 B. 41,89

Iasella40

4-6 m.

Feuille31

6 m.

52,4

47,6

Kassolis37

4-5 m.

N.R.

Simion38

7-11 m.

N.R.

Becker44

4-13 m.

N.R.

YES

Particles at a distance Remineralization of particles form preexisting near preexisting bone bone did not show remineralisation DFDBA did not show Distinguishible because of the a greater capacity to presence of separation lines and provide new bone staining characteristics formation Surrounded by vital woven or lamellar bone No correlation with Intimate association age or early barrier removal Graft particles New vital bone in close generally appeared apposition to the residual FDBA amalgamated by the particles. bone DFDBA completely Completely surrounded and embedded in the integrated newly formed trabeculae A. Osteoconduction A-B. Particles occasionally properties. B. Nonin contact with host bone. vital bone particles Retention of non-vital graft enmeshed in minimally particles. inflammed connective tissue.

FFB: fresh-frozen bone, FDBA: freeze-dried mineralized bone allograft, DFDBA: demineralized freeze-dried bone allograft, GBR: guided bone regeneration

5 months while Cammarck et al.43 reported on distinguishible particles of DFDBA and FDBA because of the presence of separation lines and staining characteristics at 6-36 months. Scarano et al.41 reported on remineralisation of particles near pre-existing bone, but

Journal of Osteology and Biomaterials

not in particles at a distance from it 6 months after grafting. Becker et al.44 in 1998 gave different histological results 6 months after grafting: FDBA and DFDBA did not appear to appreciably enhance bone formation and his work is the only one out of eleven to report

inflammation in bone core biopsies analysis. (Table 4) DISCUSSION Key findings The aim of this systematic review was to evaluate the success of bone aug-

Clementini M. et al.

mentation techniques using homologous bone as grafting material and to understand what role can homologous bone have in the future of bone augmentation techniques. Even if a limited number of studies were found in literature where allograft (block graft or particulate) was evaluated, some consideration could be drawn about graft and implant success/survival rate as well histologic and histomorphometric features. Main findings Study 1 Grafting success rate A bone graft is considered successful when the amount of bone after healing processes and bone reorganization is considered enough for implant placement11. In 12 included articles evaluating grafting success rate, the percentage of success varied from 68,18% to 100% in a follow-up period of 4-12 months. Seven works12,13,14,17,18,21,26 reported a 100% of success using DFDB and FDB for onlay bone graft, socket preservation and GBR techniques. Three authors reported, respectively, a 94,7%16, a 93%11 and a 85,7%27 of success. The only study showing a lower percentage of success (68,18%) was conducted by Gher et al.20: in this study 20 patients were rehabilitated by means of a GBR technique and DFDBA bone graft. It was very difficult to compare this data with other works reporting on grafting success using autologous or xenologous or alloplastic bone, because grafting success is not often considered as a clinical outcome, and, when considered, is not clearly defined. Anyway a recent systematic review48

about sinus augmentation reported a grafting success rate from 82,1% to 97,5% in sinus augmentation procedures using autologous bone. Other systematic reviews49,50 reported data on complications occurred in sites augmented with bone substitutes but did not specify if the grafts could be considered successful; the papers included in these reviews49,50 often reported data on combination of different bone substitutes and so they can not be considered in our comparison. Implant success rate Only two works12,13 evaluated implant success rate according to Albrektsson criteria: Fagan et al.12 and Fugazzotto et al.13 showed respectively 97,3% and 100% success rate for a total of 120 implants: 12 placed immediately in regenerated areas by means of FDBA onlay bone graft, 83 implants placed immediately after DFDBA onlay bone grafts and 25 implants placed delayed. An accurate analysis of the literature put the evidence on a severe lack of systematic reviews evaluating implant success rate for implants placed in augmented sites, so a comparison could be made only with clinical trials: one paper51 reported a 97% of success for implants placed in the upper and lower jaws after rehabilitation of the atrophic area with autograft; a 98,5% of success was reported in one paper53 evaluating dental implant success rate for 130 implants placed in sites augmented with calcium sulphate. No papers evaluating implant success rates in sites augmented with xenografts alone are available in literature.

Implant survival rate Seven works evaluated implant survival rate, plus some works which did not clearly specify the criteria of success they used. They reported a very high percentage of survival: 4 papers15,17,19,20 reported a 100% of survival for a total of 92 implants. Keith et al.16 reported a 99% of survival for 90 implants placed after a FDB graft. The lowest percentage was an 89% reported by Kassolis et al.18 for 35 implants placed after sinus augmentation and onlay bone graft procedures. A systematic review present in literature28 reported a 87,7% survival rate for implant placed in maxillary sites which had undergone sinus lift procedures through the utilization of autogenous bone. This data results to be very similar to the percentage registered in the papers included in our systematic review. Because of the lack of systematic reviews evaluating the survival rates of implants placed in sites rehabilitated with xenografts and alloplasts, a comparison of our data could be made only with clinical trials: a 95,6% of survival rate was reported after a follow up ranging from 12 to 102 months in sinus augmentation procedures performed by means of xenografts52 and a 97,5% of survival rate for implants placed in sites rehabilitated with calcium sulphate (alloplasts) in one paper54 evaluating 40 dental implants after a followup period of 4 months. Study 2 New bone formation A screening of the results suggests that the capacity of allografts to enhance new bone formation is not so similar for all the authors.

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Clementini M. et al.

Cammarck et al.43 obtained a high percentage of new bone formation for DFDBA (41,74%) and FDBA (41,89%): these results are the hightest obtained between papers included in this systematic review. One reason, probably, was the time of biopsy which ranged from 6 to 36 months, while another could be the different morphometric techniques used. Another finding from this study, which differs from the results of another article12 included in this systematic review, is that DFDBA did not show a greater capacity to provide new bone formation compared to FDBA. Scarano et al.22 registered, after 6 months, a 29% of new bone formation using DFDBA in 16 sinus elevation procedures, and this percentage is very low if compared to Cammarckâ&#x20AC;&#x2122;s study24; the percentage of new bone registered for FDBA was 28% after 4-6 months in socket preservation procedures 21 (Iasella et al.2003) and 29% after 9 months in sinus elevation procedures23 (Kolerman et al. 2008). Two results are not in line with the above mentioned works: Feuille et al.12 reported a very higher percentage of new bone formation (47,60%) using FDBA after 6 months in onlay bone graft procedures; Stacchi et al.15 reported a 48,15% of new bone formation after 5 months using FFB in 10 sinus elevation procedures in 10 different patients. Unfortunately, very different methods were used by the authors, and it wasvery difficult to draw conclusions due to the heterogeneity. No systematic reviews are present in the literature which evaluate the percentage of new bone formation after an autologous bone graft so far.

Journal of Osteology and Biomaterials

More studies are needed to compare autograft and allograft behaviour. Anyway, one paper included in our systematic review analysed the percentage of new bone formation also for autologous bone grafts: it reported a 40% new bone formation after a 6 month follow-up period in sinus augmentation techniques22. A study53 conducted in human reported a percentage of newly formed bone of 14,7% in sinus augmentation procedures using xenografts after 6,8 months of follow-up, while another paper54 reported a 33,8% of newly formed bone after sinus floor augmentations with calcium sulphate. Residual graft particles The percentage of residual graft particles also is different in the analysed works: five papers12,21,22,23,24 showed very different results which could not permit to draw any conclusions. Cammarck et al. 43 reported a very lower percentage of residual graft particles in their study because the time of biopsy ranged form 6 to 36 months. Scarano et al.22 and Iasella et al.21 reported a similar percentage of residual grafts of DFDB and FDB after 6 months (34% and 37%); Feuille et al.12 after the same period reported a 52% of residual FDB in an onlay bone graft procedure. Kolerman et al.23 reported a lower percentage of residual FDB (19%) compared to Iasella et al.21 and Scarano et al.22 and this could depend on the time of biopsy, executed after 9 months instead of 6 months. As we stated for new bone formation, there were no systematic reviews present in literature which evaluated the percentage of residual graft particles for autologous or xenologous bone.

One work22 included in our systematic review reported a 18% of residual graft particles for sinus augmentation procedures 6 months after autologous bone grafts. One paper53 present in literature reported a 29,7% of residual xenogenic material 6,8 months after sinus augmentation procedures, while another paper54 showed a 33,9% of residual graft particles 3 months after sinus floor augmentation procedures with calcium sulphate. Interaction between new bone and graft residual All 11 papers included in study n.2 of this systematic review analysed the interaction between new bone and graft residual and mostly all gave the same histological response, new vital bone was in close apposition to the residual graft particles which resulted completely surrounded and integrated in the newly formed trabeculae11,12,15,16,18,19,21,22,23,24. The results of Becker et al.25 were totally different compared to the others: particles of DFDBA and FDBA were occasionally in contact with host bone and retention of non-vital graft particles with fibrous connettive tissue was observed. The authors state that the two grafting materials did not enhance bone formation considerably , but this was the same conclusion that the author obtained for autologous bone. No systematic reviews present in the literature evaluated the interaction between new bone and residual graft particles after autologous bone graft procedures. Scarano et al22 histologically evaluated bone grafts behaviour 6 months after sinus augmentation procedures performed with autologous

Clementini M. et al.

bone and they reported a very similar behaviour of the particles if compared to homologous bone grafts conducted by the same authors. Conclusions There are clinical data supporting the potential use of bone augmentation with allografts to enable dental implant placement. Given the confined number of investigators using these techniques and the low number of patient treatments reported in the literature, the generalization of this approach is limited at this time.

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31. Feuille F, Knapp CI, Brunsvold MA, Mellonig JT. Clinical and histologic evaluation of bone-replacement grafts in the treatment of localized alveolar ridge defects. Part 1: Mineralized freeze-dried bone allograft. Int J Periodontics Restorative Dent 2003;23(1):29-35. 32. Fagan MC, Owens H, Smaha J, Kao RT. Simultaneous hard and soft tissue augmentation for implants in the esthetic zone: report of 37 consecutive cases. J Periodontol 2008;79(9):1782-8. 33. Fugazzotto PA. Implant placement at the time of maxillary molar extraction: technique and report of preliminary results of 83 sites. J Periodontol 2006;77(2):302-9. 34. Stacchi C, Orsini G, Di Iorio D, Breschi L, Di Lenarda R. Clinical, histologic, and histomorphometric analyses of regenerated bone in maxillary sinus augmentation using fresh frozen human bone allografts. J Periodontol 2008;79(9):1789-96. 35. Keith JD Jr, Petrungaro P, Leonetti JA, Elwell CW, Zeren KJ, Caputo C, Nikitakis NG, Schรถpf C, Warner MM. Clinical and histologic evaluation of a mineralized block allograft: results from the developmental period (2001-2004). Int J Periodontics Restorative Dent 2006;26(4):321-7. 36. Block MS, Finger I, Lytle R. Human mineralized bone in extraction sites before implant placement: preliminary results. J Am Dent Assoc 2002;133(12):1631-8. 37. Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol 2000;71(10): 1654-61. 38. Simion M, Jovanovic SA, Trisi P, Scarano A, Piattelli A. Vertical ridge augmentation around dental implants using a membrane technique and autogenous bone or allografts in humans. Int J Periodontics Restorative Dent 1998;18(1):8-23. 39. Gher ME, Quintero G, Assad D, Monaco E. Bone grafting and guided bone regeneration for immediate dental implants in humans. J Periodontol 1994;65:881-891. 40. Iasella JM, Greenwell H, Miller RL, Hill

M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol 2003;74(7):990-9. 41. Scarano A, Degidi M, Iezzi G, Pecora G, Piattelli M, Orsini G, Caputi S, Perrotti V, Mangano C, Piattelli A. Maxillary sinus augmentation with different biomaterials: a comparative histologic and histomorphometric study in man. Implant Dent 2006;15(2):197-207. 42. Kolerman R, Tal H, Moses O. Histomorphometric analysis of newly formed bone after maxillary sinus floor augmentation using ground cortical bone allograft and internal collagen membrane. J Periodontol 2008;79(11):2104-11 .

of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol 2008;35(8 Suppl):216-40. 49. Donos N, Mardas N, Chadha V. Clinical outcomes of implants following lateral bone augmentation: systematic assessment of available options (barrier membranes,bone grafts, split osteotomy). J Clin Periodontol 2008;35(8 Suppl):173-202. 50. Rocchietta I, Fontana F, Simion M. Clinical outcomes of vertical bone augmentation to enable dental implant placement: a systematic review. J Clin Periodontol 2008;35(8 Suppl): 203-15. 51. Elo JA, Herford AS, Boyne PJ. Implant success in distracted bone versus autogenous bone-grafted sites. J Oral Implantol. 2009;35(4):181-4.

43. Cammack GV 2nd, Nevins M, Clem DS 3rd, Hatch JP, Mellonig JT. Histologic evaluation of mineralized and demineralized freeze-dried bone allograft for ridge and sinus augmentations. Int J Periodontics Restorative Dent 2005;25(3):231-7.

52. Aghaloo TL, Moy PK. Which hard tissue augmentation techniques are the most successful in furnishing bony support for implant placement? Int J Oral Maxillofac Implants. 2007;22 Suppl:49-70. Erratum in: Int J Oral Maxillofac Implants 2008;23(1):56.

44. Becker W, Urist M, Becker BE, Jackson W, Parry DA, Bartold M, Vincenzzi G, De Georges D, Niederwanger M. Clinical and histologic observations of sites implanted with intraoral autologous bone grafts or allografts. 15 human case reports. J Periodontol 1996;67(10):1025-33.

53. Yildirim M, Spiekermann H, Biesterfeld S, Edelhoff D. Maxillary sinus augmentation using xenogenic bone substitute material Bio-Oss in combination with venous blood. A histologic and histomorphometric study in humans. Clin Oral Implants Res 2000;11(3):217-29.

45. Simon BI, Von Hagen S, Deasy MJ, Faldu M, Resnansky D. Changes in alveolar bone height and width following ridge augmentation using bone graft and membranes. J Periodontol 2000;71(11):1774-91.

54. Dellavia C, Tartaglia G, Sforza C. Histomorphometric analysis of human maxillary sinus lift with a new bone substitute biocomposite: a preliminary report. Clin Implant Dent Relat Res 2009;11 Suppl 1:e5968.

46. Gomes KU, Carlini JL, Biron C, Rapoport A, Dedivitis RA. Use of allogeneic bone graft in maxillary reconstruction for installation of dental implants. J Oral Maxillofac Surg 2008;66(11):2335-8. 47. Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent 2004;24(6):565-77. 48. Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success

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Original article

Ultrasonic vs. drill osteotomy. A clinical and histologic study in the sheep mandible. Paolo Trisi DDS, PhD1, Teocrito Carlesi DDS2*, Marco Colagiovanni DDS3, Antonello Falco DDS3, Mauro Bovi DDS4, Giorgio Perfetti MD, DDS3

Aim Most dental implants are positioned using a drilling surgery technique. However, dentistry recently experienced the implementation of piezoelectric surgery, but the implant site preparation using this tool is not reported in the literature. This study used qualitative histological examination to compare the osseointegration of implants positioned using traditional drills versus the piezoelectic bone surgery technique. Materials and Methods Implants were inserted into the inferior edges of the six sheep mandible. Four implant sites were prepared in each side of the mandibular inferior edge by using traditional standardized drill preparation on the left side and preparations with ultrasonic milling on the right side. Two sheep were sacrificed at 2 weeks (T2), two at 4 weeks (T4) and the last two sheep at 8 weeks (T8). Results Qualitative histological examination demonstrated that at time T2 in the piezo group the amount of crestal bone resorption is much less respect to the traditional drills used and the level of bone formation is much greater in the bone marrow spaces. At time T8 in the piezo group the amount of osseointegration in general is higher than the drill group, and no implant had signs of peri-implant bone resorption as did the drills groups. Conclusions In light of the present histological experimental evidence and literature data, we can state that the piezo ultrasonic device is different in affecting morphology, amount of debris and structural damage and that the processes of repair and osseointegration are positively influenced by it both in timing and in morphology of bone regeneration. (J Osteol Biomat 2011;1:21-31)

Key words: Ultrasonic osteotomies, dental implant, osseointegration, piezoelectric surgery. Bio.C.R.A.,Scientific Director of the Biomaterial Clinical and histological Research Association; Private Practice, Pescara, Italy; 2 Bio.C.R.A., Secretary of the Biomaterial Clinical and histological Research Association; Private Practice, Vasto (CH), Italy 3 Department of Oral Surgery, University of Chieti-Pescara, Italy; 4 Private practice, Roma, Italy 1

Corresponding author: *Teocrito Carlesi DDS; Biomaterial Clinical and histological Research Association, Via Conti Ricci 78, 66054 Vasto (Ch), Italy e-mail: t.carlesi@email.it

INTRODUCTION Piezoelectric surgery uses a modulated ultrasonic frequency that produces highly precise and safe hard tissue cutting. Nerves, vessels, and soft tissues are not injured by the microvibrations, which are optimally adjusted to target only mineralized tissue. Piezoelectric surgery, which takes advantage of ultrasound vibration, was introduced in an effort to overcome some of the limitations of rotating instruments in bone surgery, while increasing the cutting precision.1-2 Ultrasound technology in bone surgery has been widely used in orthopedics, otolarhyngology, maxillofacial and oral surgery 3-10. In the literature there are few studies concerning the capabilities and characteristics of ultrasonic technology in bone cutting.1-10 The advantages and disadvantages of ultrasonic cutting compared to classical, traditional drills and saws were compared and oscillating and surgical scalpels were taken into consideration. The first study was published by Mazarow et al.3 in 1960. Some authors argue that this technique of bone cutting is likely to alter and improve the processes of bone healing, especially in the first weeks compared to conventional techniques4. In oral and maxillofacial surgery, the

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technique of bone cutting using ultrasonic techniques has been reported in several surgical techniques: in the surgical removal of alveolar bone9, harvesting intraoral bone blocks or chips 11,12 , sinus lift13 , to mobilize the inferior alveolar nerve14,15. The true benefit of using this technique during the healing of the cut bone has not yet been elucidated. Some authors have reported that this new technique has positive effects on the rate of bone repair and remodelling when surgical ostectomy and osteoplasty procedures are performed10 , and on chip morphology, cell viability, and differentiation derived from grafts collected from intraoral sites.16 Dental implants are positioned most commonly using traditional drills mounted on a turning motor powered handpiece. A recently published study, conducted on pigs, evaluated the biological effects of piezoelectric implant site preparation on the periimplant bone healing.17 The authors17 report that in the early stages of the osseointegration technique appears to be more efficient in the first phases of bone healing; it induced an earlier increase in BMPs, controlled the inflammatory process better, and stimulated bone remodeling as early as 56 days post-treatment. When drilling in hard compact bone, overheating may cause cell death and subsequent bone resorption. The application of rigorous saline irrigation and low speed drilling should prevent such an event. Moreover, the use of ultrasonic appliance to perforate hard compact bone could generate enough heating to induce bone resorption. The possible effect of overheating

Journal of Osteology and Biomaterials

should be more obvious when assessed in the compatct dense bone, than in cancellous bone. The purpose of this study was to compare the development of osseointegration of implants and bone healing of implant sites prepared by a specifically designed ultrasonic tips in comparison to traditional drill implant sites prepartion. The sheep mandible was chosen as the experimental model due to its characteristics of compactness and size consistency and maturity of the cortical bone. MATERIALS AND METHODS Surgery The protocol for the study was submitted and approved by the Animal Ethical Committee at the Veterinary School of the University of Teramo (Teramo, Italy). Six hybrid female sheep aged 4-5 years old were randomly selected. Exclusion criteria were general contraindications to implant surgery and active infection or severe inflammation in the area intended for implant placement. One surgeon placed all implants. The animals were given thiopental (Thiopental; Hoechst, Austria) for induction of anesthesia as needed. After orotracheal intubation and ventilation, anesthesia was sustained with nitrous oxide-oxygen with 0,5% halothane. Physiologic saline was administered for fluid replacement. The inferior edges of the mandible were exposed through a skin incision of 15 cm in length. The skin and facial layers were opened and closed separately. After dissection of the soft tissues exposing the cortical edge, four implant sites were prepared in each side of the mandibular inferior

edge by using traditional standardized drill preparation on the left side and preparations with ultrasonic milling on the right side. The preparation on the left was followed the standards of the implant company using profuse cold saline solution irrigation internally and externally, a pilot drill of 2 mm in diameter, intermediate drill of 2.8 mm in diameter, and final tapered drill of 3.8mm. (Figure 1) Ultrasonic diamond-coated tips mounted on the machine with continuous irrigation of saline (EMS, ELECTRO MEDICAL SYSTEMS, Nyon Switzerland) with diameter (Ø 1,15 mm) for initial osteotomy, (Ø 1,95 mm and Ø 2,50 mm) for preliminary drilling, (Ø 2,80 mm and Ø 3,05 mm) for secondary drilling and (Ø 3,30 mm) for final osteotomy , were used on the right side. (Figure 2) Profuse cold saline solution irrigation was used in each step of implant site preparation and placement. The wound was closed by a resorbable periosteal-muscular inner suture followed by a cutaneous silk 2-0 external suture. Two sheep were sacrificed at 2 weeks (T2), two other sheep at 4 weeks (T4) and the last 8 weeks (T8). The sheep were sacrificed by an overdose of pentothal sodium (Thiopental; Hoechst, Austria). Implants Camlog implants (Alta-Tech Biotechnologies s.r.l., Sondrio, Italy) 3.8mm in diameter and 9mm in length were specifically utilized for this study. The implants were inserted perpendicularly in the inferior edge of the mandible. Cover screws were placed over the heads of the fixture. All the implants, were positioned after preparation of

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Figure 1. Left site, after dissection of the soft tissues exposing the cortical edge, four implant sites were prepared by using traditional tandardized drill preparation.

the implant sites with the final tapered drill achieving a good primary stability. In total 48 implants were placed. Histologic analysis The specimens were immediately fixed in 10% neutral buffered formalin. After dehydration, the specimens were infiltrated with a methyl-methacrylate resin from a starting solution 50% ethanol/resin and subsequently 100% resin, 3

Figure 2. Right side, four implant were prepared by using ultrasonic diamond-coated tips.

with each step lasting 24 hours. After polymerization, the blocks were sectioned and then ground down to about 40 microns. Toluidine-blue staining was used to analyze the different ages and remodeling pattern of the bone. HISTOLOGIC RESULTS Drill osteotomy after 2 weeks of healing We observed an initial crestal bone re-

sorption in all specimens (Figure 3). In the interfacial gap, bone chips and debris generated by the insertion of the implant were still visible (Figure 4) in areas where new vascular tissues was not yet penetrated. On the other side, in areas closer to bone marrow spaces, in which blood supply was good, new bone formation with the incorporation of the remaining bone debris could be observed (Figure 5). In areas where the

Figures 3. Initial crestal bone resorption in all specimens (original magnification x50). Figures 4. In the interfacial gap, bone chips and debris generated by the insertion of the implant were still visible (original magnification x100). Figures 5. New bone formation with the incorporation of the remaining bone debris could be observed (original magnification x100).

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Figures 6. Many chips are evident in the central canal of the mandible and a few chips at the bone-implant interface (original magnification x50). Figures 7. The bone formation was prevalent in the most apical area, particularly in the central medullary canal of the mandible (original magnification x25). Figures 8. Initial growth of new trabecular bone coronal to the implant neck (original magnification x25).

segregation of the interfacial space prevented the formation neovascular tissue the healing process was impaired and the entired space was occupied by debris of bone tissue and dead cells. Piezoelectric osteotomy after 2 weeks of healing Many chips are evident in the central canal of the mandible and a few chips at the bone-implant interface (Figure 6). A gap of about 100-200 microns is often present in the coronal level containing few inflammatory cells (PMNs). In many cases, an immature periosteal callus was present at a distance from the implant site, while near to the implant only little new bone formation was visible. Also a periosteal osteoclastic bone resorption was noticed even at some distance from the implant site. There was, in some cases, a small amount of bone resorption at the in-

Journal of Osteology and Biomaterials

terface, mainly at the crest. A minimum amount of bone resorption was sometimes observed along the wall of endosteal cortex. The bone formation was prevalent in the most apical area, particularly in the central medullary canal of the mandible (Figure 7). In some cases we observed initial growth of new trabecular bone coronal to the implant neck (Figure 8). Ultimately, the amount of crestal bone resorption was much less when compared to the drill osteotomies, while the amountl of bone formation was much greater in the medullary areas. Drill osteotomy after 4 weeks of healing Four weeks after placement, the processes of bone resorption were greatly reduced, while the process of bone formation was clearly initiated. At the crestal level, the small defects found in the first weeks were now undergo-

ing repair by newly formed bone filling the gap (Figure 9). Even in the most apical areas, an initial formation of bone bridging between the implant surface and the surrounding cortical bone was found only where the implant was very close to the cortal walls (Figure 10). Osteoid bands covered a large part of the bone surfaces. In areas where the implant had been extremely compressed to the cortical walls not yet remodeled, bone chips and debris were still found (Figure 11). On the other hand, in areas where the process of remodeling had been more active, the bone damaged by the drilling had already been partially replaced by newly formed bone. Piezoelectric osteotomy after 4 weeks of healing Four weeks after placement, resorption processes did not seem particularly active and the remodeling

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Figures 9. At the crestal level, the small defects found in the first weeks were now undergoing repair by newly formed bone filling the gap (original magnification x50). Figures 10. In the most apical areas, an initial formation of bone bridging between the implant surface and the surrounding cortical bone was found only where the implant was very close to the cortal walls (original magnification x50). Figures 11. Osteoid bands covered a large part of the bone surfaces. In areas where the implant had been extremely compressed to the cortical walls not yet remodeled, bone chips and debris were still found (original magnification x100).

Figures 12. Resorption processes did not seem particularly active and the remodeling process did not clearly replaced the interface cortical bone (original magnification x100. Figures 13. Bone debris were still visible at the interface more than in implants sites prepared with the traditional drills (original magnification x50). Figures 14. A tendency of the bone to grow in the crestal direction coronally to the cover screws was observed (original magnification x25).

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Figures 15. Bone resorption at the cortical level with a very small quantity of osseointegration (original magnification x25. Figures 16. The cortical bone near the peri-implant site has undergone a process of bone resorption that resulted in a gap between 100 and 500 microns filled with fibrous tissue and a mild to moderate degree of chronic inflammatory infiltration composed of lymphocytes and plasma cells (original magnification x200).

process did not clearly replaced the interface cortical bone (Figure 12). For this reason, bone debris were still visible at the interface more than in implants sites prepared with the traditional drills (Figure 13). In addition, a tendency of the bone to grow in the crestal direction coronally to the cover screws was observed (Figure 14). In the apical area, bone formation onto the implant surface was seen independently from the proximity of the cortical bone. At the cortical level, adaptation between implant and bone was fairly good, and the contact sites were strong being built partly around the newly formed bone and partly on native not remodeled bone. A periosteal bone formation was always found in crest at a distance from the implant. Drill osteotomy after 8 weeks of healing The implants site prepared by the drills showed a degree of maturity comparable to the ultrasound group. There were no more bone chips in the cen-

Journal of Osteology and Biomaterials

tral medullary canal of the mandible, nor at the interface. The interfacial gap was no longer visible because the bone remodeling and bone formation is eliminated. However, the cortical bone undergoes a major remodeling process that being still incompleted induced a remarkable porosity to the compact bone. There is a minimum amount of direct bone contact inside the central medullary canal of the mandible. In some cases, the growth of new trabecular bone coronal to the implant neck above the cover screw was apparent. In addition, two implants had a marked bone resorption at the cortical level with a very small quantity of osseointegration, which could be considered as a failure (Figure 15). The cortical bone near the peri-implant site has undergone a process of bone resorption that resulted in a gap between 100 and 500 microns filled with fibrous tissue and a mild to moderate degree of chronic inflammatory infiltration composed of lymphocytes and plasma cells (Figure 16).

Piezoelectric osteotomy after 8 weeks of healing All the implants inserted with piezoelectric drill achieved a good level of osseointegration. Almost all of the cortical bone interface had been remodeled and replaced by newly formed lamellar osteonic bone and a significant activity of bone remodeling was still evident in the interface. In some sporadic areas it was still possible to observe unremodelled interfacial bone with debris from the drilling (Figure 17). The appearance of peri-implant cortical bone is still very porous due to the incomplete remodeling (Figure 18). Many bone surfaces appeared to be covered with osteoid and active osteblast bands. In most cases, the crestal bone showed the tendency to grow towards the coronal direction, and in some cases the newly formed bone had covered the screws (Figure 19). The amount of osseointegration in general is higher than the drill group (Figure 20). No implant in this group had signs of peri-implant bone resorption as in the previous group.

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Figures 17. Bone resorption at the cortical level with a very small quantity of osseointegration (original magnification x25.x100). Figures 18. The appearance of peri-implant cortical bone is still very porous due to the incomplete remodeling (original magnification x25).

DISCUSSION The present study reports the qualitative histological description of the osseointegration development of dental implants placed in a site prepared by the standard drill technique or by the piezoelectric tips. In the piezoelectric group, already after two weeks, the amount of crestal bone resorption is noticeably lower than the traditional drills and the level of bone formation is much greater in the bone marrow areas. After eight weeks, in the group treated by the piezoelectric sugery the crestal bone showed the tendency to grow in the coronal direction, with osteoid formation and active osteoblasts. In some cases, the newly formed bone grew above the cover screw (Figure 19) . The amount of osseointegration in general was higher in the ultrasonic prepared group than the group prepared by the standard rotating drills (Figure 20). No implant, in this group, showed signs of peri-implant bone resorption. In the drill group, conversely, some bone

resorption at the crest was evident, no signs of crestal bone growth was evident and some implants were completely fibro-integrated and considered as failure. Since 1960 numerous experimental studies have been published on the use of ultrasound technology in cutting bone tissue3-5. Scanning electron microscope (SEM)6 studies of the cut surfaces showed that the cut the oscillating saw tended to form small bone fragments that detached from the cortical wall and left a smooth surface with parallel strips, and some microcracks, while ultrasonic cutting created a rougher surface. Histological analysis showed all the tested techniques produced a thin layer of necrotic bone with empty osteocyte lacunae probably because of the heat generated from the ultrasound equipment used at that pioneering time. In 1975, Horton et al.4 demonstrated that the use of ultrasound was less traumatic than the use of rotating instruments in an experimental study on dogs. In 1981, Horton et al.9 used ultrasonic instruments on

50 patients to perform extractions, osteoplastic surgery and periodontal bone therapy surgery. They concluded that ultrasound surgery allowed for the precise removal of bone tissue and controlled bleeding. Moreover, Horton et al.4 observed that the surface of the scalpel cut had rough edges and delamination along the planes of the adjacent lamellae. The separation was more prominent in areas adjacent to the bone marrow spaces. The ultrasonic and scalpel cuts were more irregular surface than those done by the bone chisels. In addition, delamination of the bone lamellae was more marked and no trace of overheating in the bone was found. In a similar study, Trisi et al. (unpublished data) compared cuts made in the calvaria of rabbits by piezosurgery, low speed drills and the oscillating saw. There were no signs of bone necrosis or osteocytic necrosis. The cut made with a piezoelectric tips showed a smooth and uniform surface with no signs of delamination of the lamellae or bone necrosis, while in the

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cut made with the drills or oscillating saw, much debris, and delamination of the lamellae and a more irregular bone surfaces was found. Piezoelectric tips produced an extremely linear and well defined cut both in the cortex and in the trabecular bone. Very few bone chips were present in the osteotomy space. The blood clot was located in the central area of the osteotomy without lateral dispersion. The cuts made with the oscillating saw were irregular with considerable damage in the bony walls and dispersion of bone fragments in the adjacent marrow spaces, while bone fragments were not found in the cutting space. The blood clot was located throughout the entire area of the osteotomy as well as in the

surrounding peripheral spaces. Fibrin clot adhering to the bony walls and a few white cells were also evident. Similar results were obtained in a recent study7 in which the cut surfaces were observed using different techniques. Following osteotomy with the ultrasonic device, the evaluation performed by light microscope showed a typical bone structure of the intact calvaria with an external cortex, the diploe and inner compact bone visible and well preserved. Instead, after osteotomy with conventional devices, the structure of the diploe had the following changes: the marrow spaces were filled with bone debris fragments and the trabecular structure was completely demolished. In addition, the SEM

analysis revealed a condensed and grooved surface. In a more recent study8, three types of ultrasonic equipments were compared as to the bone cutting speed and the temperature variations. The results showed that the effectiveness of cutting varies widely between different devices and that during cutting increases in temperature does not exceed 1 to 3 degrees Celsius at the maximum for all.8 Aro et al.6, in a histological study, found that the healing of defects using ultrasound instruments compared to oscillating saw, showed similar maturation processes at 6 weeks, while at 2 and 4 weeks, cutting with ultrasound showed a certain amount of connective tissue

Figures 19. The crestal bone showed the tendency to grow towards the coronal direction, and in some cases the newly formed bone had covered the screws (original magnification x25).

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Figures 20. The amount of osseointegration in general is higher than the drill group (original magnification x50).

development resulting in a delayed healing. In a comparative histological study between the surgical chisel and the ultrasonic instrument, Horton et al.4 revealed numerous differences in the first weeks of healing that disappeared into the third month. Three days after cutting, the chisel and the ultrasonic defects had been filled by a fibrovascular granulation tissue with almost complete replacement of the blood clot. Cellular organization was found in some areas along the cut bone surfaces with good evidence of osteoid formation4. The defects produced by the drills still had the initial blood clot and an inflammatory infiltrate composed of polymorphonuclear leukocytes, while osteoclast activity was minimal and osteoid formation was not observed4.

After seven days, the osteoclastic activity in cut areas produced by the ultrasonic device was significantly reduced. The new bone formation was now also evident within the defect. In general, the formation of new bone was more advanced in the defects created with a chisel in amount and maturity, while the bone formation in the drill defects was delayed. After 14 days of healing, the amount and maturation of bone defects in the chisels produced defects seemed to be more advanced when compared to those produced by the ultrasonic instrument. All samples evaluated at 28 and 56 days after surgery showed a progressively greater amount of bone formation. It became difficult to distinguish the differences between the three types of cuts. The ninetieth day, the original defects pro-

duced by the three instruments could no longer be distinguished from each other because of the significant bone remodelling. In a similar study, Trisi et al. (unpublished data) did not observe substantial differences between the piezoelectric scalpel, the drill and oscillating saw in the first days following the surgery. At a distance of 7 and 14 days however, a difference in the amount of bone formation inside the wound was evident, since the cuts made with the drill and the piezo show the most complete degree of filling than the cuts made with the saw. In the literature, we found only one study17, conducted on pigs, which evaluates the biological effects of the healing of dental implants placed in sites prepared by piezoelectric sur-

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gery. The authors19 reported that in the early stages of the osseointegration the piezoelectric technique appears to be more efficient in the first phases of bone healing, because it induced an increase in the amount of BMPs, a better controll of the inflammatory process, and stimulated bone remodelling as early as 56 days post-treatment.

Journal of Osteology and Biomaterials

CONCLUSIONS In conclusion, we observed significant differences between different instruments for bone osteotomy. Using modern ultrasonic devices, the cut surface are smoother and more uniform without signs of delamination of the lamellae or bone necrosis, while in the osteotomies prepared by the drill or oscillating saw bone debris, delamination of the lamellae and irregular bone surfaces were observed. When analyzing the healing of implant site prepared by the piezoelectric device, repair and bone formation appeared faster and less aggressive than traditional drills. The bone growth in a coronal direction tended to cover the implant cover screws; while in traditional osteotomies we observed the formation of an infracrestral bony defect. In addition, while some implants in the sites prepared with drills showed signs of failure, none of the implant in the group treated by the piezoelectric system showed signs of severe bone resorption. Finally, in light of the present histological evidence and on the base of the literature data, we can affirm that the ultrasound osteotomies present different morphology, amount of debris and structural damage and that the processes of bone repair and osseointegration are positively influenced by the use of ultrasonic devices, both in timing and in morphology of bone regeneration.

ACKNOWLEDGEMENTS The authors wish to thank Alta-Tech Biotechnologies for providing the implants used in this study, and EMS ELECTRO MEDICAL SYSTEMS for providing the ultrasonic diamond-coated tips and the Piezon Master Surgery. Partially financed by the Department of Oral Surgery. University of ChietiPescara, Italy and by Bio.C.R.A. (Biomaterial Clinical and histological Research Association), Pescara, Italy.

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REFERENCES 1. Ercoli C, Funkenbusch PD, Lee HJ, Moss ME, Graser GN. The influence of drill wear on cutting efficiency and heat production during osteotomy preparation for dental implants: a study of drill durability. Int J Oral Maxillofac Implants 2004;19(3):335-49. 2. Harris BH, Kohles SS. Effects of mechanical and thermal fatigue on dental drill performance. Int J Oral Maxillofac Implants 2001; 16(6):819-26. 3. Mazarow HB. Bone Repair After Experimentally Produced Defects. J Oral Surg 1960;8:107-113. 4. Horton JE, Tarpley TM, Jr., Wood LD. The healing of surgical defects in alveolar bone produced with ultrasonic instrumentation, chisel, and rotary bur. Oral Surg Oral Med Oral Pathol 1975;39(4):536-546. 5. Mcfall Ta, Yamane GM, Burnett GW. Comparison of the cutting effect on bone of an ultrasonic cutting device and rotary burs. J Oral Surg Anesth Hosp Dent Serv 1961;19:200209. 6. Aro H, Kallioniemi H, Aho AJ, KellokumpuLehtinen P. Ultrasonic device in bone cutting. A histological and scanning electron microscopical study. Acta Orthop Scand 1981;52(1):5-10. 7. Maurer P, Kriwalsky MS, Block VR, Brandt J, Heiss C. Light microscopic examination of rabbit skulls following conventional and Piezosurgery osteotomy. Biomed Tech (Berl) 2007; 52(5):351-355.

electric osteotomy for intraoral harvesting of bone blocks. Int J Periodontics Restorative Dent 2007;27:127-31. 12. Happe A. Use of a piezoelectric surgical device to harvest bone grafts from the mandibular ramus: Report of 40 cases. Int J Periodontics Restorative Dent 2007;27:241-9. 13. Wallace SS, Mazor Z, Froum SJ, et al. Schneiderian membrane perforation rate during sinus elevation using piezosurgery: clinical results of 100 consecutive cases. Int J Periodontics Restorative Dent 2007;27:413-9. 14. Bovi M. Mobilization of the inferior alveolar nerve with simultaneous implant insertion: A new technique. Case report. Int J Periodontics Restorative Dent 2005;25:375-83. 15. Sakkas N, Otten JE, Gutwald R, Schmelzeisen R. Transposition of the mental nerve by piezosurgery followed by postoperative neurosensory control: A case report. Br J Oral Maxillofac Surg 2008;46:270-1. 16. Chiriac G, Herten M, Schwarz F, et al. Autogenous bone chips: Influence of a new piezoelectric device (piezosurgery) on chip morphology, cell viability and differentiation. J Clin Periodontol 2005;32:994-9. 17. Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G. Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol 2007;78(4):716-22.

8. Harder S, Wolfart S, Mehl C, Kern M. Performance of ultrasonic devices for bone surgery and associated intraosseous temperature development. Int J Oral Maxillofac Implants 2009;24(3):484-490. 9. Horton JE, Tarpley TM Jr, Jacoway JR. Clinical applications of ultrasonic instrumentation in the surgical removal of bone. Oral Surg Oral Med Oral Pathol 1981;51:236-42. 10. Vercellotti T, Nevins ML, Kim DM, et al. Osseous response following resective therapy with piezosurgery. Int J Periodontics Restorative Dent 2005;25:543-9. 11. Sohn DS, Ahn MR, Lee WH, et al. Piezo-

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BioCRA

Original article

Bone tissue integration with immediately loaded implants in aesthetic zone. A four year prospective clinical study Luca Di Alberti DDS, PhD1*, Federica Donnini2, Michele Camerino DDS2, Claudio Di Alberti DDS, MSc2, Lorenzo Lo Muzio MD, DDS, PHD3

Aim In the esthetic zone, a key challenge for the restorative dentist is to provide patients with a crown and periimplant mucosa that are in harmony with the adjacent teeth, thus restoring both function and esthetics. The aim of this study is to confirm this data and introduce a new concept for the creation of papillae. Materials and methods 70 patients were treated with single tooth implants with immediate functional loading of the provisional crown. 25 Seven速 implants (MIS, Israel) were inserted in single post-extraction sites and the remaining 45 Seven速 implants (MIS, Israel) were inserted in healthy bone. Results and Conclusions All implants were stable and radiographically osteointegrated after 12 months of control. No implant failure was recorded. Results from the present study show promising results on the immediate loading of single implants for the replacement of missing teeth. Promising results, are also shown advocating the compression of the papilla eight weeks after implant placement for the maintainance of bone and papilla height. (J Osteol Biomat 2011;1:33-41)

Key Words: Dental implants, Immediate functional loading, Single tooth,

Provisional Crown.

Private Practitioners 1 Contract Professor in Implant Prosthetics, University of Foggia, Italy 2 Private Practitioners, Chieti-Pescara, Italy 3 Professor and Director, Dental Department, University of Foggia, Italy *Corresponding author: Dr Luca Di Alberti, DDS, PhD Via Colonnetta, 22-A, 66013 Chieti, Italy dialbertiluca@yahoo.it

INTRODUCTION Single-tooth implants have a high longterm success rate1-9. Several studies have demonstrated predictable results on immediate implant insertion into extraction sockets 8-18. This high level of success in implant therapy have encouraged the re-evaluation of several aspects of the traditional implant protocol 19-22. Several authors have demonstrated successful immediate loading of edentulous mandibles with fixed superstructures23-26 or bar-retained overdentures27-31. Immediate loading of oral implants has been defined as a situation where the superstructure is attached to the implants no later than 72 h after surgery 32,33 . The definition of immediate loading also includes occlusion with the teeth of the opposite jaw. Under these conditions, successful immediate loading of screw-type dental implants has been reported as early as 1979 27. The experience in immediate occlusal loading of oral implants has led to different consensus papers 32-34. The large number of consensus statements and reviews suggests that immediate loading is a field that is still developing, and currently leaves room for different interpretations. In the esthetic zone, a key challenge

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Figures 1 and 2. First Upper Incisor with lasrge composite and metal post. The tooth present a periapical lesion with decay of the remaining root. Radiological and clinical appearance.

for the restorative dentist is to provide patients with a crown and periimplant mucosa that are in harmony with the adjacent teeth, thus restoring both function and esthetics. From a surgical perspective, the current concept is to plan for implants to be placed in a position to optimize the emergence profile of the restoration, thereby achieving proper soft tissue form and symmetry35. It also known that when a single tooth is missing the buccal bone reduce its volume while the mesio distal bone crests remain in place. Following this theory a more palatal and central positioning of the single implant should lead to a complete restoration of the esthetic area with a correct positioning of the bony papillae which guides the soft tissues. This ‘restorative-driven’ surgical concept is thought to be an important factor in achieving esthetic success. Several data confirm that implants placed into extraction sockets may be expected to integrate with a high degree of predictability36,37. The aim of this study is to confirm this data and introduce a new concept for the creation of papillae.

Journal of Osteology and Biomaterials

MATERIALS AND METHODS In the course of our investigation, 70 patients were treated following an immediate loading protocol with SEVEN® implants (MIS, Israel). All patients were treated with single tooth implants and immediate functional loading of the provisional crown. 25 Seven ® implants (MIS, Israel) were inserted in single post-extraction sites and the remaining 45 Seven ® implants (MIS, Israel) were inserted in healthy bone (Figs 1,2,3). All implants were inserted with a final torque >40Ncm. 33 implants were placed in male and 37 implants in female patients, the mean age of the patients being 45 years (mininum 16 years, maximum 71 years) (Table 1). The treatment course included permanent wear of an temporary crown for a minimun of 12 weeks. Patients were informed of all the risks and consent was obtained. Oral examination focused on stable occlusion, soft tissue conditions, buccolingual and mesiodistal width and maxillomandibular relationships. The patients were required to comply with the follow-up and maintenance pro-

gram. Tomograms or periapical and panoramic radiographs were evaluated for mesiodistal width (interradicular distance), volume and direction of the residual bone beyond the apex, socket width, buccal bone plate and root angulation. Indications for tooth extraction and immediate implant placement included trauma resulting in tooth avulsion1 or root fractures2, periodontal attachment loss5, endodontic failures2 or non-restorable crowns2. Following careful luxation of the root with a periotome, sixteen teeth could be removed easily (Fig. 4). In four cases, implant site preparation was performed with the intra-alveolar part of the root in situ. After final drilling with a 3.00-mm twist drill, thereby expanding the internal root canal, remaining root structures were elevated with a periotome. Installation of the screw type sandblasted acid etched SEVEN implants was achieved according to the instructions of the manufacturer with an increasing torque up to 45Ncm thus measuring mechanical bone quality and primary stability of the implants (TC). Final implant position was achieved utilising a torque driver, giving special attention to the position of the internal hexagon to optimise chairside restoration of the abutments. Finally, MP01 abutments (MIS, Israel) were screwed to the implants (Fig. 5) and the wound closed with single mattress sutures for the open flap cases (Fig. 6). In ten sites, implant placement was performed through the socket opening without any incision. Patients received oral antibiotics for 8 days, starting one day prior to surgery,

Di Alberti L. et al.

Figures 3 and 4. Fractured root with decay of first upper incisor (11). SevenÂŽ implant inserted a time 0 and at 2 week. Mesial and distal bone peaks are preserved.

as well as non-steroidal analgesics and instructions for oral hygiene with chlorhexidine (0.12%) post-operatively. In the immediate implants placed without incision, the remaining incongruencies between the screw and the surrounding bone were left untreated. In two cases with flap elevation and peri-implant gaps, bone granules and a biodegradable membrane (MIS, Israel) were applied and exact adaptation of the soft tissue margins ensured. All implants were immediately restored with temporary screwed provisional crowns, manufactured with the help of single shell crowns, or clear vacuumformed templates, and adjusted to the abutment and the gingival margin with acrylic resin (Pro Temp, Espe, Seefeld, Germany). Special attention was placed for the identification of centric and eccentric contacts on the provisional crowns. Finishing of the acrylic resin restorations was performed on abutment analogues in the laboratory to avoid removal of the abutment screwed onto the implant. Finally, all patients were provided with occlusal contacts.

Regular controls were performed at 2week intervals with special attention to occlusion and hygiene (Fig 7). Intraoral radiographs with digital sensor positioning systems (RVG, Kodak) using the righ tangle technique were taken monthly. A single patient RVG sensor holder was created using Rinn mouthpiece and Pattern resin (GC) for occlusal repositioning for the whole period of the study. The Rinn with Pattertn resin added gave a perfect and stable guidance for X-Ray analysis. Any manipulation except re-screwing of loose provisional restorations was avoided. After 8 weeks the provisional crowns and the abutments were modified as necessary to create compressions and realases of the sourronding soft tissues to enhance the aesthetic of the gingival margin. After a healing period of 4 to 6 months, the provisional crown was removed and, using a transfer coping, impressions with polyether (ImpregumA F polyether-impression material, Espe) were taken. A maxillary and a mandibular cast were prepared, mounted on an articulator (SAM, Munich, Germany) and the definitive restoration was man-

ufactured, either on crown abutments or all-ceramic abutments (MIS, Israel). The definitive restorations were inserted 20â&#x20AC;&#x201C;24 weeks after implant placement with temporary cement (Temp Bond). The clinical criteria to be evaluated at this point were survival, Ostell values and radiographic bone levels. After delivery of the superstructure, patients were included in a regular 3 months maintenance program during the first year. Twelve months after implant insertion, intraoral radiographs

Figure 5. Provisional crown prepared to screwed to the implant at surgical time.

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Figure 6. Provisional inserted at surgical time.

Figure 7. Provisional at 7 day from surgery.

were taken and compared with the corresponding radiographs from the time of implant insertion and 6 months post insertion. Clinical data were evaluated every six months for four years.

infrabony pockets. The patients expressed a very high level of treatment satisfaction (Figs. 10 and 11). All the periapical radiographs of the inserted implants were evaluated for marginal bone change. Assessment of radiographic change in bone level over time showed no statistically significant difference in marginal bone loss between the mesial and distal sides at each time frame. Figures 8 and 9 show the evolution of the mean marginal bone loss and growth over time. The most pronounced crestal bone loss was observed during the first 2 months and decreased thereafter. The observed bone loss was similar to that reported using delayed loading protocols38. All implants were clinically stable and met the success criteria. The overall implant success rate was 100%. Table 4 shows the cumulative implant survival and success rate up to 12 and 48 months of follow-up.

RESULTS None of the patients dropped out from the study. Healing was, in general, uneventful with little pain and swelling for the patients. Complications were restricted to loosening of the provisional crowns or final restorations (Table 2). All implants were inserted with a final torque >40Ncm. 33 implants were placed in male and 37 implants in female patients, the mean age of the patients being 45years (mininum 16years, maximum71 years) (Table 1). All the implants (70) were stable as tested by Ostell and by rotation at 35Ncm after removal of the FCDs at the 12 weeks follow-up examinations. The overall OH status evaluated after removal of the prostheses was judged to be good around 78% of the implants, fair around 20% and poor in the remaining 2%. The results from the examinations of the peri-implant mucosal status and probing around the implants placed in healed bone and extraction sockets did not reveal any

Journal of Osteology and Biomaterials

DISCUSSION In several studies on immediate loading, a large number of inclusion and exclusion criteria have been defined39-45. These criteria are similar to those chosen for conventional loading of dental

implants46. From the data available in the current literature, no conclusions can be drawn concerning relevant exclusion and inclusion criteria for immediate loading of oral implants, and controlled studies are needed to address this problem. In most of the studies on immediate loading, good bone quality has been mentioned as an important prognostic factor for the success of the procedure39,47. Although this conclusion seems reasonable, the level of evidence that supports this assumption is low. The same is true for the implant lengths and diameters that should be used for immediate loading. In a controlled study, rough implant surfaces improved the survival rate of immediately loaded implants48; however, the influence of the rough as opposed to machined surfaces was not significant. Review papers on immediate loading have addressed additional biomechanical aspects of this procedure22,49,50. Based on different experimental stud-

Figure 8. X-Ray of SEVEN速 implant at 15 days from loading.

Di Alberti L. et al.

Table 1.

PATIENT CODING 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37

AGE

GENDER

35 36 42 47 65 64 28 70 65 57 34 45 71 21 25 37 32 40 38 44 44 47 16 51 65 46 56 67 69 34 28 49 39 41 36 63 36

M M F M F M F M M F F M F F M F M M M F F M F M M F F F M M F F M M F F M

TYPE OF IMPLANT 420 375 375 375 375 375 375 420 420 420 420 420 420 420 375 375 420 420 420 420 375 375 375 375 420 420 420 420 375 420 420 420 375 420 420 375 420

PATIENT CODING 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70

AGE

GENDER

26 29 56 39 48 35 34 29 59 49 35 36 44 46 47 37 57 55 59 30 55 54 45 48 53 39 55 29 34 43 59 65 39

M F F M F M F M F F F F F F M F F F M F M M M M F M M F F F M M F

TYPE OF IMPLANT 420 420 375 375 375 420 420 420 420 420 375 420 420 420 420 375 375 420 420 420 420 375 420 420 420 375 420 420 420 375 375 375 420

45,0142857142857

37:F 33:M

26:3.75mm 44:4.20mm

Age, Sex and Type of implant inserted.

ies, they have stated that a micromotion threshold should not be exceeded; otherwise, osseointegration would be hindered. The critical threshold seems to be 50â&#x20AC;&#x201C;150 mm51-53. Therefore, it has been claimed that a high initial stability is necessary for immediate loading of dental implants54,55. For this purpose, these authors used modified drilling

protocols combined with bone compaction with osteotomes to achieve increased primary stability. Some authors have chosen insertion torque as a measure of implant stability, and arbitrarily select torque values of 32, 35, 40Ncm and higher as thresholds for immediate loading41,56,57. However, successful immediate loading of

an implant with an insertion torque of 15Ncm has been shown under some conditions55. Until now, there has been no reported controlled study that has compared the relationship of different implant stability levels with the implant survival rate. Consequently, there is currently no proven threshold value that indicates

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Table 3.

TYPE OF IMPLANT AND CLINICAL SITE 3.75 -- 22 3.75 -- 23 3.75 -- 23

PATIENT CODING 41 6 33

COMPLICATION FITTING SCREW LOOSENING FITTING SCREW LOOSENING DECEMENTING CROWN

Complications total data Table 4.

TOTAL IMPLANT 70

SURVIVAL RATE 100%

SUCCESS RATE 100%

Survival and success rate

Figure 9. X-ray of SEVEN速 implant at 6 months. Perfect preservation of mesial and distal bone peaks.

Figures 10 and 11. Clinical appearance at 4 years.

Journal of Osteology and Biomaterials

that immediate loading will be successful. Besides high initial stability, it has been stressed that immediately loaded implants in multi-unit situations should be rigidly splinted by their superstructures58,59. In order to optimize splinting, metal reinforced superstructures have been used; however, it could be shown that high success rates may be achieved with superstructures that were not metal reinforced58. Again, there are no evidence-based data that support the hypothesis that superstructures supported by immediately loaded implants should be metal reinforced. As rigid splinting is not possible for single-tooth implants, immediate restorations without or with reduced occlusal contacts have been advocated for single tooth implants by some authors54,56,60,61. Again, there is no evidence-based protocol for loading of single-tooth implants. In controlled studies, the survival rate of immediately restored single-tooth implants was comparable or slightly lower than that of conventionally loaded singletooth implants60,62. The former had a restoration placed immediately, and occlusal contacts were removed or avoided. Some authors even tried to protect these implants from forces

exerted by the tongue or soft food by using occlusal splints57. Is also known that when a single tooth is missing the buccal bone reduces its volume while the mesio distal bone crests remain in place. Following this theory a palatal and central positioning of the single implant had lead to a complete restoration of the esthetic area. The presence of the mesio and distal bone peak of the adjacent teeth and the correct positioning of the implant in a tridimensional view lead to a correct restoration of the biological and esthetic of the bony papillae and soft tissues surrounding. To date, there are no controlled studies that would permit evidence-based decisions as to whether single-tooth implants can be loaded immediately or should only be restored without occlusal contacts. CONCLUSIONS Results from the present study show promising results on the immediate loading of single implants for the replacement of missing teeth. Promising results also advocate the preservation of the bony papilla after eight weeks of implant placement for the maintainance of the bone and papilla height.

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BioCRA

Original article

Porous hydroxyapatite custom made cranioplasty: the 3D design techniques prostheses in 21 patients Corrado Iaccarino1*, Vania Ramponi1, Reza Ghadirpour1, Francesco Carinci2, Franco Servadei1

Aim The authors report the use of hydroxyapatite (HA) for cranioplasty. None of several materials used to reconstruct skull defects is fully satisfactory, due to biological and physical properties. HA seems to be an ideal support for bone regeneration due to the high porosity. The ultrastructural bio-mimetism promotes osteoblast migration into the prosthetic core, and low post-implant inflammatory and infective risk. Materials and methods From February 2007 to September 2010 HA custom made cranioplasty have been implanted in 21 patients (16M/5F; age range 21-66) at the Neurosurgery Unit of the Emergency Department of the University Hospital of Parma, Italy. No particular criteria were pre-established, the main indications for HA prostheses as first line were complex and/or extended post-surgery craniolacunia (48%). As second line the HA prostheses were implanted after unsuccessful heterologous (24%) or autologous (28%) cranioplasty due to rejection, infection or operculum reabsorption. A stereolithograpic model in epoxy resin of the cranium was obtained from a 3D CT scan study of each patient . The prostheses were built on this model using a ceramic sintering process, with the same porosity of the skull’s spongy bone, with interconnected macropores (>150μm). Results Each patient obtained an excellent aesthetic result. The mean time surgery were around 90 minutes. There were no reabsorption, rejections or spontaneous fractures. In only one case the HA prosthesis was revised due to infective complications. The patient was a 20 years-old boy with a 6-years clinical course with two previous different cranioplasty revision due to infective complications recurrence. Conclusions HA prostheses is a valid alternative to traditional cranioplasty techniques both aesthetically and in terms of absence of infections / rejections. The main limit of the ceramic is its elevated costs, that did not allow the routinary use of the HA as first line choice for the treatment of craniolacunia. (J Osteol Biomat 2011;1:43-53)

Key words: skull defect, ceramic, porous hydroxyapatite, cranioplasty, decompressive craniectomy 1 2

Neurosurgery Unit – Emergency Department – University Hospital of Parma 1 Section of Maxillofacial & Plastic Surgery - Department of Medical-Surgical Sciences of Communication and Behavior - University of Ferrara, Italy

Corresponding author: *Corrado Iaccarino, MD Neurosurgery Unit – Emergency Department – University Hospital of Parma Viale Gramsci, 14 – 43100 – Italy Phone: +393483827441, Fax: +390521704634 e-mail: ciaccarino@ao.pr.it

INTRODUCTION A recent literature review shows that decompressive craniectomy (DC) (mono- or bi-lateral) is a reconsidered therapeutic choice mainly for treatment of post-traumatic cerebral oedema1-10, but also for cerebrovascular desease such as cerebral infarction, aneurysmal subarachnoid hemorrhage (SAH)11-14. This has led to a considerable increase in the number of patients surviving severe brain damage and having surgical cranial lacunae to be corrected. The essential qualities for this skull vault repair appear to be at least: first, resistant, second, biocompatible i.e. maximal reduction of the inflammatory reaction and rejection due to an immunological compatibility15-21 and third, integrable with the living surrounding bone in order to become a part of it. The autologous bone graft remain the treatment of choice. When the difficulties of storage, anatomical conditions and the infectious complications lead to loss of the bone flap when a supple primary repair cannot be proposed 22,23 an alloplast graft cranioplasty is required. Several materials are available such as polymethylene methacrylate (PMMA), titanium, acrylic resins (AR) or hydroxyapatite (HA) in cement or ceramics24. HA meets the requirements of

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Figure 1. Custom Made cranioplasty project obtained by processing 3D CT scans for each individual patient.

high biocompatibility 15,16.19,20,25-30, bone substitution and osteointegration30, good osteoconduction due to the porosity 31-33. Moreover, the computed assisted 3D design and manufacturing the cranioplasty has improved the cosmetic result and reduced the operative time for implantation 28,34-36. The “Custom made” devices in synthetic porous HA from processing of CT images can be used for insertion of cranial prostheses, with good aesthetic results and no infection/rejection. In this system, the bioceramic acts as a mechanical support and an osteomimetic micro-environment able to promote new bone formation.

Journal of Osteology and Biomaterials

MATERIALS AND METHODS Between february 2007 and September 2010 21 HA cranial prostheses were implanted at the Neurosurgery Unit of Emergency Department of University Hospital of Parma. The mean age of treated patients was 31 years (range 11 to 66), with a predominance of male patients (16/5). The epidemiologic data of the study population are summarised in table 1. The HA prostheses were implanted as first line in 48% of the cases, mainly due to extended area of the craniolacunia, or complexity of the bone edges craniectomy, further indication when the autologous bone were unavailable. 24% of patients received a second line treatment with HA

Figure 2. a. Epoxy resin solid model with identical shape and size of the entire patient’s cranium using 3D stereolithography, produced by a laser beam, which solidifies a thin layer of a liquid epoxy resin surface on contact. b. A model of the device is then produced, equal to the patient’s bone defect.

prostheses after heterologous implant failure, while in 28% of cases the HA prostheses were implanted after reabsorption of autologous bone cranioplasty. Each patient was the subject of an individual project to produce a Custom Made device obtained by processing 3D CT images (Fig. 1) and constructing an epoxy resin mould of the entire cranium using 3D stereolithography (Fig. 2a). This method is based on the effect produced by a laser beam, which solidifies a thin layer of a liquid epoxy resin surface on contact. Layer by layer, a solid model with identical shape and size to the patient’s skull is obtained from the 3D virtual model.

Iaccarino C. et al.

Table 1.

AGE Range: AVG: 16 Male AVG: 5 Female AVG:

11-66 31 29 35

SITE Par-Temp: Front-Par-Temp: Parietal: Front-Par: Front-Temp:

38% 24% 19% 5% 1%

HYDROXYAPATHITE INDICATIONS First line 48% Second line (after eterologous implant) 24% Second line (after autologous implant) 28% CAUSE OF DECOMPRESSIVE CRANIECTOMY Trauma 90% Tumor 10%

Epidemiological data of 21 patients with HA cranial prostheses implanted between february 2007 and September 2010 at the Neurosurgery Unit of Emergency Department of Universitiy Hospital of Parma.

A model of the device is then produced, equal to the patientâ&#x20AC;&#x2122;s bone defect (Fig. 2b), and a block of porous HA (technology patented by Fin-Ceramic Faenza) is crafted to produce a mould equal to the approved model (Fig.3), which is then surgically implanted (Fig.4). During the surgical implantation phase, care was taken to ensure adherence to the bone edge, which must be freshened, with high-speed drilling, to ensure the

maximum contact between the device and the cranium, and to favor the osteoconduction of the implant. The prosthesis was then fixed with silk thread through anchoring holes. These holes are previously planned during the design phase of the epoxy resin test model (Fig.5) At the moment of the surgery the prostheses is still fragile, so it is not possible to use micro-screws or rigid fixing systems, due to the risk of

inducing micro-fractures. For this reason for each patient a back up copy of the prostheses is produced ready to be implanted in case of damaging of the first copy. After fixation of the prosthesis, when available the temporal muscle was anchored in all pterion flaps, to avoid an unaesthetic result due to its retraction/atrophy. Each prostheses of this report was made using Fin-Ceramica FaenzaÂŽ (s.r.l,

Figure 3. Block of porous HA (technology patented by Fin-Ceramic Faenza) is crafted to produce a mould equal to the approved model

Figure 5. Preparation of an extended bifrontal cranioplasty. Anchoring holes previously planned during the design phase, drawn on the epoxy resin test model

Figure 4. Surgically implanted custom made porous HA cranioplasty. The prostheses is fixed with silk thread to the cruented bone edges and to the dural surface. The anchoring holes of the prostheses are planned during the design phase of the epoxy resin test model

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Figure 6. Infective complication recurrence of heterologous (Titanium mesh and PMMA) and bone autologous cranioplasty in the same 20-years old patient a. 2004 CR scan control of titanium mesh and PMMA cranioplasty (arrow) b. During the follow up the patient showed a postoperative wound ulceration (double arrows) with subsequent cranioplasty removal for infective Complication c. 2006 3D CT scan control of autologous bone cranioplasty with autologous bone insertions taken from controlateral parietal vault d. During follow up the patient developed a reopening of the wound due to infective complication (circle) e. Cranioplasty removal with initial osteomyelitis signs of the bone edges

Italy) supplied by Codman速. Prostheses design and production conform rigorously to Attachment VIII of Directive 93/42/CE, which regulates the application of made to measure devices. RESULTS All patients underwent clinical checkup and a 3D CT 3,6,12,18 months after surgery. The mean clinical follow-up was 18.2 months (range 4.3-38.9). Each patient obtained an excellent aesthetic result with a simplified surgical proce-

Journal of Osteology and Biomaterials

dure The mean time in the Operating Theatre was around 90 minutes. There were no reabsorption, rejections or spontaneous fractures. In only one case the HA prosthesis was revised due to infective complications. The patient was a 20 years-old boy with a 6-years clinical course of infective complications recurrence. In 2004 a titanium mesh and PMMA cranioplasty was implanted after decompressive craniectomy due to severe traumatic brain injury (Fig. 6a) in a different isti-

tution. After 2 months the wound presented an ulceration due to infective complication (Fig. 6b), and 5 months postoperatively the cranioplasty was removed. The autologous bone flap was implanted after 1 year. The cranioplasty was completed with some bone fragments taken from the controlateral parietal skull vault (Fig. 6c), but two months later an infective complication occurred which prevented healing of the wound (Fig. 6d) and 3 months later, despite antibiotic and hyperbaric ther-

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Figure 7. After 13 months the back up copy of the prostheses was re-implated a. Preoperative CT scan showing extended craniolacunia with midline shifting due to atmospheric pressure effect on the malacic brain b. Immediate postoperative CT scan after the second HA prosthesis surgical implant

apies, the infected autologous cranioplasty was removed (Fig. 6e). After 18 months the patients was admitted to the Neurosurgery Unit of Department of Emergency of the University Hospital of Parma. An HA prostheses was implanted and 3 months after was removed soon after first infective complication appearance of the wound. After 13 months the back up copy of the prostheses was re-implated (Fig. 7). Still now the patient is under close clinical observation. DISCUSSION The DC is a neurosurgical procedure correlated with current controversy about the therapeutic efficacy, patientsâ&#x20AC;&#x2122; selection, and surgical timing. In 2006 a Cochrane Database Study for the treatment of refractory high intracranial pressure (ICP) in traumatic brain injury (TBI)37 reports no evidence to support the routine use of secondary

DC to reduce unfavourable outcome in adults with severe TBI and refractory high ICP. Howewer the analyzed nonrandomized trials and controlled trials with historical controls involving adults, suggest that DC may be an useful option when maximal medical treatment has failed to control ICP. Moreover, an increasing number of papers report the DC for the treatment of refractory high ICP after massive MCA ischemic infarction, after SHA for ruptured aneurysms, and other conditions such as brain infections or sinus thrombosis 11-14,38,39. After the clinical acute phase of the brain damage, a secondary repair of the craniectomy, defined as the cranioplasty24, is required. The cranioplasty decreases the barotraumas to the brain, improves the regional cerebral blood flow, prevents the motor trephined syndrome and reduces the alterations of cerebrospinal fluid dynamics40. Still now the right indication is an exponentially

growing problem and is greatly debated in neurosurgical practice, especially to individuate which patient will benefit after cranioplasty. Actually the main indication is to satisfy cosmetic and protective results, lessen the risk of direct trauma to the craniectomy site41. The ideal material for cranioplasty prosthesis construction must be resistant, biocompatible, to eliminate the risk of inflammation, rejection and infection, and integrable with the living bone structure to the point of becoming a part of it, promoting osteoblast migration3,42-48. Wherever it is possible the patientâ&#x20AC;&#x2122;s own operculum should be the ideal solution, but osteomyelitis, reabsorption of the reimplantation (Fig. 8), and difficult conservation often make this method ineffective49-53. Bone tissue is a composite material constituted by about 22% organic matrix (of which 90% is collagen) with the rest being mineral (69%) and water (9%). The mineral component is hydroxyapatite, a calcium/phosphor crystal in the ratio Ca/P = 1.67 18,42,46,54. Its mechanical properties are closely related to the ratios of the inorganic and organic components. The organic component confers bone tissue with a much better ability to absorb impulsive mechanical energy (resilience), greater mechanical resistance and lower rigidity with respect to the bioceramic component alone. The bone substitute should be biocompatible, non-carcinogenic, nonbiodegradable, produce no fumes and no toxicity, easy to design and manipulate the shapes, sterilizable and usable with stereolithography. Many materials are available for cranioplasty. titanium, PMMA, and other resin and alloy types,

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Figure 8. Autologous bone cranioplasty failure. a. After 30 month of implantation the CT scan shows reabsorption of the border (red arrows) of the autologous graft b. Postoperative CT scan of HA prosthesis implanted

without fullfilling the biocompatibility requisites (27,28,30,55-62). The most common heterologous material used is PMMA. Overall, the failure rate due to complications such as rejection, pros-

Journal of Osteology and Biomaterials

thesis movement, infection, and aesthetic inefficacy (Fig. 9) is from 14-22%, according to international case studies8 and the release of bio-incompatible compounds, related to the cement’s

polymerisation 8,63,64. The synthetic porous HA chemical formula Ca10(PO4)6(OH)2 is the same mineral composition as that of the bones and teeth of vertebrates (Fig. 10). The HA prostheses are characterised by an high interconnectivity, a bimodal porosity distribution with 6070% of macropores and 20% of micropores 42,17,21,65,66 (Fig. 11). Experimental studies reported as the macro-porosity allows bone cells colonization in the matrix of the prosthesis and the osteoconduction leading to new bone formation (Fig. 12). Development of a ceramic material consisting almost entirely of HA (96.7%), with porosity properties very similar to those of natural bone while maintaining sufficient rigidity and mechanical resistance, allowed to achieve a solid, pre-moulded model of the bone defect, as a framework for osteoblast progression and mineral reabsorption and re-deposition. Its chemical affinity with the main component of bone’s mineral matrix (Ca5(PO4)3OH) makes HA both biocompatible and bioactive. The multi-mode pore distribution promotes osteoinductivity. Except for the first 12 weeks after implantation, the bioceramic material guarantees equal biomechanical resistance to bone tissue (Boyde, Cocchi, NAtaloni, Nataloni, Nataloni). The method’s current limitation is its high cost, especially when compared with the autologous bone patient’s own operculum. For this reason, it is indicated mainly for cases of large defects with rejection, infection or poor aesthetic result of previous prosthetic implants.

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a b

Figure 9. PMMA manual modelled cranioplasty failure due to prosthesis movement a. 3D CT scan showing aesthetic unefficacy, without bone integration b. Immediate CT scan postoperative HA implant to control right positioning respect to the bone edges craniolacunia

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Figure 10. Structural bio-mimetism of the synthetic HA

Figure 11. Synthetic HA with an high interconnective porosity (40% - 70%), and a percentage (around 60 – 70%) of macropores (diameter greater than 150 µm) and around 20% micropores (with diameter less than 10 µm)

Figure 12. Scanning Electron Microscopy Analysis of Implantation of porous hydroxyapatite (HA) in a bone defect of sheep iliac crest (courtesy of Finceramica®). The macro-porosity allows cells colonization from the host bone (B) and osteoconduction leading to new bone formation (NB) a 20 days follow-up after implantation b 40 days follow-up after implantation

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CONCLUSIONS The progress made in recent years has also led to the development of a three dimensional support with the properties of biocompatibility and biodegradability, such as calcium and phosphorous based materials (HA). Digital technology has enabled three-dimensional images to obtain the development of custom-made prostheses, combining these technologies with stereolithography. The production and implant of HA prostheses was found to be a reliable method in 21 cases, with significant failures in terms of complications or consequences were reported on follow-up. Actually, due to elevated costs, HA for cranioplasties is interesting for complex and/or extended post-surgery craniolacunia, when the autologous bone of the patientâ&#x20AC;&#x2122;s own operculum is unavailable, and it could not be a choice as a first line treatment of craniolacunia. ACKNOWLEDGENTS We would like to thank Dr. Angelo Nataloni, fully employed by Fin Ceramica, who gave permission to use the pictures of the experimental studies and ultrastructural features of HA. The other Authors did not receive grants and have no personal or institutional financial interest related to the submission of this paper.

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Volume 2 - Number 1 - 2011

BioCRA

Original article

Skeletal height estimation from regression analysis of clavicular lengths in Northwest Indian cadavers of Chandigarh region Jagmahender Singh PhD1*, Raj Kamal Pathak PhD 2

Aim Stature estimation from maximum clavicular length and mid-articular distance of the clavicles collected from 252 male and 91 female autopsied subjects of Chandigarh zone of northwest India is the topic of discussion in this study. Materials and Methods Sexualdimorphism was found evident in both the clavicular dimensions, males having longer clavicles than the females. Both the clavicular lengths had a positive and significant correlation with cadaver length/ stature of the deceased (P<0.001). Regression analysis revealed that multiple regression analysis was more useful for stature estimation than the linear one. The R-square and Fratio were found to be statistically significant for both the variables in two sexes Results The stature estimates calculated from wet clavicle measurements were found more accurate and precise than the dry bones. The left clavicle gave more accurate and precise skeletal height estimates than the right clavicle. The universal regression analysis proposed by Kanchan et al., when applied to clavicular lengths, gave satisfactory estimates of stature in males only. In females, stature was better estimated from simple linear regression analysis. Conclusions On the whole, the clavicle was not found a good estimator of living height as compared to other long bones. However, in the absence of availability of other length contributing long bones, clavicle may be a useful adjunct for estimating stature. (J Osteol Biomat 2011;1:55-67)

Key words: Osteology, clavicle, biological profile, stature estimation, regression analysis, Northwest Indians. Anthropologist, Department of Forensic Medicine and Toxicology, Govt. Medical College and Hospital, Chandigarh, India 160030

2 Professor of Anthropology and Coordinator, Institute of Forensic Science and Criminology, Panjab University, Chandigarh, India 160014 Email: rajrkpathak@hotmail.com

Corresponding authors: *Jagmahender Singh. 905 B, Sector- 43A, Chandigarh, India 160022 E-mail: jagmindera@yahoo.com Phone: +91 9417048690 Fax: 0172 2608488

INTRODUCTION The biological profiling of unidentified and badly dismembered human skeletal remains retrieved from a crime or a mass casualty site is one of the most challenging tasks for the forensic experts involved in identification of victims of such incidents1. Stature estimation is a crucial component of identity of such individual/s found killed or missing in such disasters. It is well documented that there exists some biometrical and proportional relationship between every human bone or body segment and the stature of an individual2, and such a proportion does not alter with age when complete skeletal maturity has been attained3, 4. Since Pearson5, different workers have devised different regression formulae for stature estimation using different bones or body segments, for different populations2, 6-9. However, the applicability of such formulae is reported to be strictly population and sex-specific and thus, are not considered suitable for estimating stature of other populations10-13 without considering secular trends and adjusting age-correction factors8. Trotter and Gleserâ&#x20AC;&#x2122;s14 regression formulae calculated from long bone measurements are widely used for the purpose but with much precautions as they are utilized only as â&#x20AC;&#x2DC;in-

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• To assess whether the universal regression formulae of clavicular dimensions are useful to estimate stature of a deceased from a clavicle of unknown sex recovered from forensic or bioarchaeological contexts.

Figure 1. Illustration of landmarks for measuring maximum clavicular length and mid-articular distance of clavicle.

formative prior’ in forensic science15. The stature predicted from skeletal elements is quite different than that estimated from body segments of a living or a dead person, as the former estimates don’t take into consideration the thickness of inter-osseous soft tissues, lordosis and kyphosis16, 17. Furthermore, the living stature of a standing person is about 2.5 cm less than the cadaver length, possibly due to compression of soft inter-osseous tissues and loss of tonicity of longitudinal vertebral muscles in the erect standing posture16, 18. In the Indian context, a number of stature estimation formulae have been developed for different regions using either the bones collected from cadavers18,19-22 or from various body dimensions like foot length23,24, hand length25,26, cephalofacial dimensions27-29, footprints30, finger lengths31, length of vertebral column18, footsteps or stride lengths32, etc. The clavicle is incidentally the only long bone of human skeleton placed

Journal of Osteology and Biomaterials

horizontally in the body, but morphologically it doesn’t contribute to the standing height of an individual. The utility of clavicular length in stature estimation is either rarely explored or has been a matter of dispute; with Singh and Sohal19 finding it useful and Jit and Singh20 refuting the same. From the available literature accessible to the authors, no study conducted for stature estimation from clavicle could be found other than the above two above referred studies conducted about six decades ago. The present study was conducted with the following objectives: • To explore the suitability of clavicle in stature estimation by analyzing any correlation that may exist between its lengths and stature/cadaver length. • To investigate whether this horizontally placed long bone is equally important for stature estimation from regression analyses of its measurements like other vertically placed long bones of human skeleton.

MATERIALS AND METHODS Population data The present study was conducted on 343 pairs of clavicles (Males, 252; Females, 91) collected from adult autopsy cases (18-94 years) brought for medico-legal postmortems at the Department of Forensic Medicine, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. The age mentioned in the hospital records or police inquest forms was confirmed from the next kin of the deceased and in case of any difference between two enquiries; the age reported by close relatives was recorded. The deceased had been admitted and died at this hospital because of various medico-legal causes like accidents, poisoning, burns, etc. Ethical clearance was obtained from the institute for the purpose and with the valid consent of legal heirs of the deceased, the clavicles were collected. The included subjects in this study demographically belonged to five northwest Indian States of India i.e., Punjab, Haryana, Himachal Pradesh, western part of Uttar Pradesh and Union Territory of Chandigarh. The entire sample area falls in the northwestern part of India whose inhabitants were basically agriculturists belonging to the same distinctive cluster, same ethnic group and sharing similar food habits, gene frequencies and other distinguishing traits33, though some

Jagmahender S. et al.

with some observable morphological variations amongst them. The cases of other regions/states were not considered in order to avoid any distortion in the measurements of the studied parameters as people of different zones of India have been reported to have different clavicular measurements34-42. The majority of male subjects of the present study were involved in manual laborious work, while almost all the females were housewives. Methodology Both the clavicles along with sternum was as a single piece removed by giving incisions at the acromio-clavicular, sterno-olecranon and costo-sternal junctions. Clavicles of only right handed persons were collected as handedness is reported to influence the metric measurements of bones43. Each bone was washed, cleaned and prepared for measurements as per the standard procedures prescribed by the earlier workers. The pair of clavicle showing features like fractures, visible pathology, surgical repairs, skeletal abnormality or deformity, arthritic depositions around ends etc., that would affect/distort the measurements, was excluded from the study sample. The wet bones were cleaned with gauze piece and dried using a hair-dryer to remove any moisture on the surface. Each pair of clavicle was metrically measured and replaced into the dead body after conduction of postmortem as the ethical constraints imposed by the institute didn’t permit prolonged de-fatting or drying. Thus, present study data is from wet bones with lesser chances of shrinkage taken to be ideal for estimation of correct living stature of the cadavers. All the

measurements including cadaver length were measured in centimeters by one observer (i.e., first author) to avoid any technical and/or inter-observer error and to maintain reproducibility of the results.. Each of the following measurement was taken three times and their average was recorded for analyses and comparisons. Postmortem stature/cadaver length (CL) Before autopsy, the body was placed in supine position on the flat and hardsurfaced postmortem table, with knee and hip joints extended and the neck and feet in a neutral position. The cadaver length (stature) of each cadaver was measured between the vertex of the head and the base of the heel using a measuring steel tape to the nearest 0.1 cm as per the technique used by Nagesh and Kumar18. This was taken as cadaver length or postmortem stature of the deceased. In the present study, the length was measured at the time of autopsy and not when the body was received in the department as done by Jit and Singh20. Maximum clavicular length (MCL) It is the maximum distance measured between the innermost tip of the sternal end to the outermost part of the acromial end of the clavicle placed on an osteometric board (ignoring curves of the bone) accurate to within 0.5 cm (Fig. 1) as per the technique used by McCormick et al.44. Mid-articular distance (MAD) It is the distance between the midpoints of the sternal and acromial articular ends of clavicle measured with the

help of a spreading caliper with pointed ends, accurate to within 0.5 cm (Fig. 1) as per the technique used by Ray45. Statistical analyses The statistical analyses for various measurements were performed by using ‘SPSS 16.0 Student Version’ statistical software, Chicago, IL46. The correlation coefficient was calculated to assess any relationship that may exist between cadaver length and the clavicular lengths, and also to select an independent variable for stature estimation. ‘Student t-test’ was performed to test whether there exists some sexual dimorphism in the means of measurements.. Both linear (LRA) as well as multiple regression analysis (MRA) was done to derive regression equations of stature estimation from the clavicular measurements. The hypothetical regression equation is represented as Stature (S) =a+bX, where ‘S’ stands for stature, ‘a’ is the intercept or regression coefficient of dependent variable, ‘b’ stands for the slope or regression coefficient of independent variable and ‘X’ is the mean clavicular length of a particular parameter. Since body proportions in relation to stature in two sexes of a specific population are not variable47, the data of two was pooled up for calculation of universal linear regression equations [URA]. Rsquare (R2), standard error of estimate (SEE) and F-ratio were calculated to assess the significance of regression. R2 determines the degree of association of correlation that exists between any clavicular length and the stature/ cadaver length, higher the value of R2, better is the fit and more useful is the regression equation as a predictive de-

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Table 1.

Age interval (years) 17 – 25 26 – 35 36 – 45 46 – 55 56 – 65 66 – 75 > 75 Total (%)

Punjab M

Haryana F

19 19 24 8 21 2 12 8 10 4 5 2 2 0 93 44 137(39.94)

28 9 30 10 13 0 6 4 2 3 3 1 3 0 85 27 112 (32.65)

Himachal Pradesh M

14 4 11 3 8 1 4 2 4 1 1 1 0 0 42 12 54 (15.74)

Chandigarh M

6 4 6 1 3 0 1 0 1 0 0 1 0 0 17 6 23 (6.70)

Western UP M

Total N

6 1 4 0 4 0 1 0 0 1 0 0 0 0 15 2 17 (4.96)

110 98 52 38 26 14 5

% 32.07 28.57 15.16 11.08 7.58 4.08 1.46 343 (100)

Demographic profile of study population [males=252, females=91] Table 2.

Males (n=252) Measurement

Range

Mean±SD

Females (n=91) Correlation Coefficient

Range

Mean±SD

Cadaver Length (S)

151.0136.10168.11±7.19 4.28 1.00 156.28±6.98 185.10 177.00 12.8012.00MCL-R 14.90±0.86 5.77 0.551 13.47±0.79 16.90 15.40 13.1012.20MCL-L 15.24±0.86 5.64 0.603 13.77±0.80 17.40 16.00 12.2011.80MAD-R 14.40±0.84 5.83 0.526 13.12±0.75 16.50 15.10 12.5012.00MAD-L 14.74±0.87 5.70 0.587 13.38±0.75 17.00 15.50 Statistical descriptive of various clavicular measurements along with stature in males and females. ** Significant at 0.001 level CV= Coefficient of Variation

vice and vice-versa. The standard error of estimate is measure of spread of errors along a straight line and it measures the accuracy of estimated figure; smaller is its value, better will be the estimate and vice-versa. The stature of study sample was estimated from the derived regression equations, and was compared with the actual postmortem stature of the cadavers to assess the accuracy of such formulae. RESULTS Sample Distribution Table1 shows that a majority of subjects belonged either to the laborer or farm-

Journal of Osteology and Biomaterials

ing community of two major agricultural states (Punjab and Haryana) of northwest India. The mean age of male and female cadavers was 36.4±15.48 years and 35.3±16.45 years, respectively, and a majority of subjects belonged to the age-group of 17-25 years (32.07%) or 26-35 years (28.57%). Table 2 shows that the mean cadaver length/stature of males was 168.11±7.09 cm and that of females were 156.28±6.98cm, and such a difference in two sexes was found to be statistically significant (p<0.001). Both the clavicular lengths were significantly more in males than the females and the

Correlation Coefficient

t-Test

4.47

1.00

8.733**

5.86

0.503

14.40**

5.81

0.532

14.67**

5.72

0.529

13.47**

5.61

0.546

14.13**

left clavicles were significantly longer than the right clavicles for both the dimensions in two sexes. The coefficient of variation (CV) was slightly more in males than the females. The cadaver length was positively and significantly correlated with both the clavicular lengths of both sides, but comparatively more with the left and the male clavicles than the right and female clavicles. The correlation coefficient varied from 0.526 to 0.603 in males and from 0.503 to 0.546 in females. The studied parameters in females were comparatively less correlated with stature than in males.

Jagmahender S. et al.

Table 3.

Males (N=252 pairs)

Variable

Females (N=91 pairs)

(S)=a+bx

SEE

F-Value

(S)=a+bx

SEE

F-Value

MCL-R (X1)

99.55+4.60(X1)

0.304**

6.01

109.02

96.77+4.42(X1)

0.253**

6.07

30.18

MCL-L (X2)

91.13+5.05(X2)

0.364**

5.75

143.14

92.53+4.63(X2)

0.283**

5.94

35.19

MAD-R (X3)

103.53+4.84(X3)

0.244**

6.13

95.67

91.99+4.90(X3)

0.280**

5.96

34.58

MAD-L (X4)

96.83+4.84(X4)

0.345**

5.83

131.49

88.54+5.06(X4)

0.298**

5.88

37.76

Linear regression equations (LRE) for stature estimation from various clavicular lengths in males (N=252) and females (N=91). ** Significant at 0.001 level

Linear Regression Analysis Table 3 shows the linear regression analysis results for stature estimation from the studied parameters of clavicle. The coefficient of determination (R2) was found to be significantly more for the left and the male clavicles than the right and female clavicles. Maximum clavicular length in males and the mid-articular distance in females were found better indicators of stature in linear regression analysis. On the whole, the maximum clavicular length was found a better estimator of stature than the mid-articular distance. The SEE was comparatively less for left clavicles than the right ones. Table 7 shows the comparison of mean actual stature (MAS) from mean estimated stature (MES) from linear regressions Multiple Regression Analysis Different combinations of parameters were subjected to the stepwise multiple regression analysis for the individu-

al sex as well as for the pooled data of two sexes (Table 4). The R-square was found to be higher in males than the females and still more for the pooled data The females had higher SEE than the males and thus were comparatively less reliable for the purpose. When both the variables of two sides were considered in the analysis or the left side clavicular parameter was used in any of the combinations, the R-square was found comparatively more than when only right side clavicular parameters were used in the regression. Table 6, 8 shows the comparison of mean actual stature from mean estimated stature from multiple regressions. The pooled data showed much higher R2square than the individual male and female data. R value was higher when left clavicular lengths were used in any combination and maximum clavicular length in males and mid-articular distance in female were better correlated with stature in present study. In pooled

data, URA gave smaller regression coefficients but higher R2 values and SEE. DISCUSSION Unlike anatomical methods, the mathematical methods of stature estimation are commonly used worldwide and are based on regression analysis of certain bone measurements taken on the complete or fragmentary bones. Traditionally, the intact long bones especially of lower limbs13 recovered from crime or mass-disaster sites like terrorist massacres, traffic accidents, tsunamis, wars or military intrusions, earthquakes etc., are considered better for reconstructing the stature of the victims. However, the recovery of intact long bones in all forensic scenarios is a chance factor and can never be guaranteed, or they may not be suitable for the purpose, hence forensic experts are left with no option other than to explore the possibility of using other bones for stature estimation. Though adult human

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Jagmahender S. et al.

Table 4.

Clavicular lengths entered/ selected

Sex

Regression formula for Stature estimation(S=)

SEE

F-ratio

91.131+5.051 (MCL_L)

0.364**

5.75

143.14

88.537+ 5.063 (MAD_L)

0.298**

5.88

37.76

96.827+4.837(MCL_L)

0.364**

5.75

143.137

92.525+4.629(MCL_L)

0.283**

5.94

35.19

96.827+ 4.837(MAD_L)

0.345**

5.83

131.492

88.537+5.063(MAD_L)

0.298**

5.88

37.78

99.554+4.601(MCL_R)

0.304**

6.01

109.019

91.989+4.900(MAD_R)

0.280**

5.96

37.76

91.131+5.051(MCL_L)

0.364**

5.75

143.137

74.280+6.107 (MCL_L)

0.340**

6.00

400.95

Pooled

74.280+6.107 (MCL_L)

0.540**

6.00

400.95

Pooled Pooled Pooled Pooled

74.280+6.107 (MCL_L) 76.200+6.175 (MAD_L) 79.393+5.894 (MCL_R) 74.280+6.107 (MCL_L)

0.540** 0.522** 0.494** 0.540**

6.00 6.12 6.30 6.00

400.95 371.80 333.00 400.95

MCL_R+ MCL_L+ MAD_R+ MAD_L

MCL_R+ MCL_L

MAD_R+ MAD_L

MCL_R+ MAD_R

MCL_L+ MAD_L MCL_R+ MCL_L+ MAD_R+ MAD_L MCL_R+ MCL_L MAD_R+ MAD_L MCL_R+ MAD_R MCL_L+ MAD_L

Multiple stepwise regression analysis of clavicular measurements for the individual sexes as well as for the pooled data ** P < 0.001

stature is genetically determined48, the long-term genetic changes14, 49, ethnic, temporal or secular trends10, 49, 50, socioeconomic or environmental factors like nutritional status51, 52, allometric changes in long bones50, the immigration of populations within different parts of world etc., are the factors inducting variations in stature among individuals of a population or different populations. As sexual dimorphism of stature is evident in every known human population53, stature estimation for-

Journal of Osteology and Biomaterials

mulae have been derived for two sexes separately. But if the body proportions in relation to stature are similar in the two sexes or sex remains unknown or cannot be determined with reasonable accuracy, universal regression formulae can be used for stature estimation from skeletonized human remains47. The clavicle is considered a long bone of the human skeleton because it has a medullary cavity and an epiphysis at both ends to permit growth like other vertically placed long bones of human

skeleton. Much of its adult morphology is attained early in fetal growth and its double-curved S-shaped morphology is achieved well before birth54, thus leaving further growth to occur primarily at the ends, especially the medial epiphysis55. Some workers even took this bone as superfluous in human skeleton, merely giving attachments to a number of muscles and serving no function otherwise56, 57, but it has been found medico-legally important for estimation of sex34-44, age58-66 and

Jagmahender S. et al.

Table 5. Author

Ethnicity/ region

Terry69

USA (Negroes)

Ray45

Australian

North American Amritsar Jit and Singh34 (Indian) Varanasi Singh and (Indian) Gangrade35 Chandigarh Jit and Sahni36 (Indian) Bangalore 37 Sayee et al. (Indian) Chandigarh Singh and Jit38 (Indian) Patiala Kaur et al.40 (Indian) Chandigarh Kaur et al.41 (Indian) Chandigarh Present study (Indian) McCormick et al.44

Right clavicle

N M-50 F-50 M-65 F-45 M- 560 F- 164 M- 236 F- 112 M-100 F- 100 M- 280 F- 80 M-138 F-118 M- 563 F- 209 M- 100 F- 100 M- 748 F- 252 M- 252 F- 91

t-test† F

Left clavicle

t-test†

153.30±0.83 140.98±7.62

-7.78**

-4.60**

155.86±9.23

141.78±8.31

-2.44*

-2.81**

139.5±9.30

123.5±7.31

7.41**

8.13**

140.7±9.31

125.1±7.10

9.13**

9.26**

157.0±9.50

140.0±7.90

-11.89** -5.12**

159.0±9.11

141.0±7.70

-9.95** -3.19**

145.58±8.60 130.36±9.11

4.39**

3.62**

147.59±9.25

129.80±8.77 5.94**

6.68**

141.49±8.22 125.78±7.50

7.61**

7.96**

144.18±8.01

127.77±8.09 8.48**

8.49**

1.34

1.83

149.8±8.40

134.0±8.10

3.52**

2.99**

148.00±8.60

132.4±8.40

137.00±9.00 123.90±8.00 12.77**

9.71**

141.15±13.00 128.20±9.00 9.11**

8.03**

147.12±9.13 132.22±7.44

2.83**

2.54*

148.20±8.87

133.18±7.62 6.39**

4.55**

146.89±9.23 132.62±7.68

1.97*

1.84

148.27±9.21

133.98±7.97 3.85**

3.20**

149.40±8.91 134.53±9.68

-0.63

0.16

151.14±8.72

136.21±9.64

149.00±8.60 134.70±8.00

152.40± 8.60 137.70± 8.00

2.01*

1.44

Comparative statistics of maximum clavicular length, mm (mean±SD) studied by different workers **Significant at 0.01 level † t-values for comparison with present study * Significant at 0.05 level

stature19, 20 etc., of an individual. In the recent past, this bone has been rarely used for stature estimation. No racial differences have been reported in clavicular features. In the present study sample, there were more than 60% individuals who died in young age of 17 to 35 years because of different medico-legal reasons. The mean cadaver length was found higher in the present study than the average cadaver length found by Singh and Sohal19 for the same strata of northwest Indian population of Chandigarh region. The apparent difference in average living stature of two studies is probably because of pooling of both sexes in the study conducted by

Singh and Sohal19. Better living conditions, improved nutritional status, etc., available to the present study subjects, secular trends or the procedural differences might be responsible for such a difference in the cadaver length. The mean living stature of Gujjars of Patiala (a region covered in present study also) was found to be at 166.4±5.6 cm for males and 159.6±5.1cm for females by Kanchan et al., 23. Rastogi et al31 found the male and female living stature to be 171.60±6.62cm and 158.66±6.06cm, respectively for a particular north Indian population. The difference in cadaver length and the living stature of subjects of recent population may also be due to compression of soft tis-

sues between inter-vertebral discs in a standing person. The difference with earlier reported studies may be due to wet nature of present study clavicles, measuring techniques of the investigators, and inter-observer variations, etc. Sex differences or sexual dimorphism in length of clavicle was also apparent in present study results as observed by previous workers34-44, 68, males having larger clavicles than females. Table 5 shows that in present study both side maximum clavicular lengths were significantly larger than almost all earlier Indian studies34-42 and smaller than the English or American studies44,69. The length was almost similar to more recent past Indian study conducted by

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Jagmahender S. et al.

Table 6.

Variables used in regression

Sex

Mean

SEE

Variance

Correlation with actual body stature

MCL_R+MCL_L+ MAD_R+MAD_L

M F M F M F M F M F

168.11 156.28 170.54 156.28 168.11 156.28 168.11 156.28 168.11 156.28

4.34 3.81 4.16 3.72 4.22 3.81 3.96 3.69 4.34 3.81

0.27 0.40 0.26 0.39 0.27 0.40 0.25 0.39 0.27 0.40

18.84 14.51 17.28 13.80 17.84 14.51 15.71 13.64 18.84 14.51

2.58 2.44 2.44 2.38 2.51 2.44 2.36 2.36 2.58 2.44

0.603 0.546 0.603 0.532 0.587 0.546 0.551 0.529 0.603 0.546

MCL_R+MCL_L MAD_R+MAD_L MCL_R+MAD_R MCL_L+MAD_L

Mean stature estimated from sex-specific multiple regression equations in males (N=252) and females (N=91) with mean difference from the actual stature

Kaur et al41. Similarly, left-biased bilateral asymmetry was found in both the measurements (i.e., maximum clavicular length and mid-articular distance), probably because of right handedness of the subjects of this study 41, 70. The mean clavicular length was found greater than the earlier studies on stature estimation19, 20, though mean multiplication factor was found similar to that calculated out by Singh and Sohal19 suggesting a biometrical/proportional relationship between cadaver length and clavicular length for present population vis-à-vis the population 5-6 decades ago. In the present study, the correlation coefficient between cadaver length (stature) and the two clavicular dimensions varied from 0.526 to 0.603 in males and from 0.503 to 0.546 in females, being higher for left clavicles in both sexes. The previous studies on vertically placed six long bones (like femur, humerus, tibia, radius etc.,) showed a correlation coefficient ranging from 0.70 to 0.90 or more for dif-

Journal of Osteology and Biomaterials

ferent populations, higher for lower limbs than the upper limbs16, 71-75. The correlation values were higher for the’ pooled data’ (male and female values mixed up) where the coefficient was always higher than 0.494 and lower than 0.540. When the sample was separated by sex the correlations were slightly lower. The clavicle had a weaker correlation with body length as compared to other long bones, even from the miniature long bones of human skeleton i.e., metatarsals and metacarpals76. A wet clavicle is 1-3 mm longer than a dry clavicle16, so the predicted stature from the clavicular measurements considered in the present work will be more accurate accordingly than that estimated from the dry bones by previous workers. Table 8 shows that male cadaver length is comparatively better correlated with maximum clavicular length in almost all the studies reported in accessible literature. The findings of the present study support Jit and Singh20 in that the stature of an individual can be estimated bet-

ter if the left clavicle is measured [Table 8]. However, this study is not inagreement or is unanimous with their finding that, on the whole, the length of the clavicle doesn’t have any empirical relationship with the actual height of an individual. The cadaver length and clavicular lengths of both side clavicles of both the sexes were found positively and significantly correlated in our study. Singh and Sohal19 also found that such a relationship between cadaver length and clavicular lengths have some medico-legal significance. Earlier studies on clavicle reported that neither multiplication factors nor regression formulae were useful for estimation of height of an individual from clavicle within a reasonable degree of accuracy19,20. Contrary to this, both of these mathematical operations gave better stature estimates for the subjects of present study, though not at par with other studies on vertically placed long bones of human skeleton. The derived regression model for the randomized pooled data was com-

Jagmahender S. et al.

Table 7.

Males (MAS=168.1)

MAS → Measurement ↓

Females (MAS=156.3) MES calculated using LRE

MCL-R

168.1

156.3

MCL-L

168.1

156.3

MAD-R

173.2

156.3

MAD-L

168.2

156.2

Comparison of mean actual stature (MAS in cms) with mean estimated stature (MES in cms) calculated by using linear regressions (LRE) in males (N=252 pairs) and females (N=91pairs).

Table 8.

Variables taken in regression

MCL_R+ MCL_L+ MAD_R+ MAD_L

MCL_R+ MCL_L

MAD_R+ MAD_L

MCL_R+ MAD_R

MCL_L+ MAD_L

Sex

Mean Estimated stature

SEE

Variance

Mean diff from actual stature

Range of difference from actual stature

167.35

5.25

0.33

27.54

3.14

+0.76+5.81

-16.16_23.39

158.39

4.90

0.51

24.03

3.09

-2.106+6.03

-16.09_13.56

167.35

5.25

0.33

27.54

3.14

+0.76+5.81

-16.16_23.39

158.39

4.90

0.51

24.03

3.09

-2.11+6.03

-16.09_13.56

167.21

5.39

0.34

29.07

3.22

+0.91+5.94

-16.70_24.20

158.82

4.65

0.49

21.59

2.93

-2.53+5.91

-17.12_12.50

167.21

5.08

0.32

25.78

3.04

+0.90+6.10

-16.74_23.68

158.77

4.69

0.49

21.95

2.95

-2.49+6.15

-17.45_13.91

167.35

5.25

0.33

27.54

3.14

+0.76+5.81

-16.16_23.39

158.39

4.90

0.51

24.03

3.09

-2.11+6.03

-16.09_13.56

Mean stature estimated from universal regression equations in males and females with mean difference from the actual stature ‘-‘sign shows that estimated stature is more and ‘+ ‘sign shows that estimated stature is less than the actual stature, respectively.

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Table 9.

Worker Jit and Singh20

Side Right Left Pooled Right

Kaur et al.41 Left Right Present study

Left Pooled

Coefficient of correlation 0.68 0.72 0.69 M- 0.4643 F-0.3984 M- 0.4730 F-0.4160 M- 0.55 F- 0.50 M- 0.60 F- 0.53 M- 0.60 F- 0.53

Standard error of estimate 6.57 6.17 6.42 M- 6.01 F- 6.07 M- 5.75 F- 5.94 M- 6.01 F- 5.75

Correlation coefficients and SEE of cadaver length with maximum clavicular length studied by different workers

pared with sex-specific linear regression models and it was found that the former gave better results than the former. But such formulae can be useful only when stature of a clavicle of unknown sex is to be estimated. The mean actual stature of the deceased was compared with the mean stature estimated from the linear as well as multiple regression equations in both sexes (Table 7, 8). From linear regression, estimated stature was found to be much closer to the actual stature, except mid-articular distance of right clavicles in males. Table 8 shows that from URA, the mean male stature was underestimated by about 1 cm and that of female stature was overestimated by 2 cm. The estimated error from right clavicles was found more than 4 cm (estimated by Singh and Sohal19 i.e., -36.36 to 22.46 mm. Similarly for left clavicles, it was between -31.92 to 21.9 mm20. In the present study, the estimated stature was closer to the actual stature in males with mean difference

Journal of Osteology and Biomaterials

varying from 0.76 to 0.91 cm, but in females the mean difference was much higher i.e., -2.11 to -2.53 cm. The multivariate regression analyses clearly revealed two things; firstly, the combination of clavicular lengths is more useful than the individual length for stature estimation from regression analysis; secondly, the left clavicular lengths are more useful than the right ones. Thus, we can sum up that multiple regression analysis is better suited for males than females. The pooling of data appears to be better for living stature estimation of the clavicles of unknown sex or whose sex cannot be ascertained with reasonable accuracy. It is generally accepted that stature in different populations start to decline with age, probably around mid-fifties14,77-79. As populations begin to decrease in stature in their misfortunes, so stature loss adjustments on account of aging must be considered while estimating stature in individuals older than 45 years of age78,79. The careful analysis

of results of present study reveal that this horizontally placed long bone is not equally suitable for stature estimation like other vertically placed long bones of human skeleton as correlation coefficients and R2 values are markedly lower than that reported for other stature-specific long bones. Even if a fragmentary clavicle is recovered from a forensic site, its actual length can be closely approximated80 and hence living stature can be reconstructed from the regression equations presented here.

Jagmahender S. et al.

Conclusions Stature estimation from clavicular lengths can be a valuable but supplementary adjunct for identification of victims of mass casualties when intact long bones are not retrieved Males had significantly higher measurements than females, thus corroborating previous studies. North Indians and males were taller with greater clavicular lengths than the South Indians and the females, respectively. The multiple regression equations were found more useful and reliable for stature estimation than the linear ones. The R-square and F-ratio were found to be statistically significant for almost all the variables in both the sexes. Though universal equations for predicting stature give better results for males, but they are not proposed for the subjects of known sex as they underestimate the male and overestimate the female stature. The linear regression is more reliable for female stature estimates than males in this study. Our study concludes that clavicle may be of vital importance for stature estimation only when other long bones are not available, as clavicular lengths exhibit comparatively weaker correlation coefficients with stature and higher standard errors of estimate than earlier studies. Clavicle as a long bone was not so good for stature estimation as long limb bones of extremities. And application of these formulae should be restricted to the population sample for which they have been derived. Further studies on large sample sizes and on different populations need be carried out to confirm or negate the findings of the present study. A larger sample study covering different Indian populations is needed to suggest uniform regression equations of stature pre-

diction from clavicular measurements. More research is needed for formulation of some universally accepted stature estimation formulae from clavicle by compiling databases for different populations around the world considering the secular trends in stature, allometric changes in long bones and the immigration of populations within different parts of world including India. Considering that clavicle is indeed one of the best preserved and complete bones in forensic anthropological situations, the results obtained may be useful in positive identification in assessing the biological profile.

Acknowledgements The authors would like to extend warm appreciations to Professor Krishan Vij, ex-Professor and Head, Department of Forensic Medicine and Toxicology, for his scientific advice and encouragements by sparing the first author from his routine departmental work for data collection at PGIMER for his doctorate degree in Anthropology (Forensics), and also for his valuable suggestions and guidance for preparation of this manuscript. The data used here is from doctorate thesis work of the principal author.

Limitations of study The present study was conducted on freshly collected but cleaned wet clavicles, and no such study was available to the authors for direct comparisons. The bones undergo shrinkage on drying. Therefore, similar studies (on wet as well as dry bones) are required for different parts of the world to confirm or negate these findings and to investigate the significance of any difference that exists between dry and wet clavicles. It is not recommended that these formulae be applied to samples outside the geographic range covered in this study Conflict of interests Authors have no financial or personal conflict of interest about this manuscript and have complete possession of the data of present study and take responsibility for integrity and analysis of the data.

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Journal of Osteology and Biomaterials

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42. Patel J, Shah GV. Sexing of known human adult clavicles in Gujarat zone. 51st proceedings of Anatomical Society of India at NHLM Medical College, Ahamdabad, 2004;53(1): 31-66.

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57. Abbott LC, Lucas DB. The function of the clavicle: its surgical significance. Annals Surg 1954;140(4):583-99.

43. Auerbach BM, Raxter MH. Patterns of clavicular bilateral asymmetry in relation to humerus: variations among humans. J Hum Evol 2008;54(5):663-74.

58. McKern TW, Stewart TD. Skeletal age changes in young American Males: analyzed from the standpoint of age identification Headquarters Quartermaster Research and Development Command Technical report EP45,1957.

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44. McCormick WF, Stewart JH, Green H. Sexing of human clavicles using length and circumference measurements. Am J Forensic Med Path 1991;12(2):75-181. 45. Ray LJ. Metrical and non-metrical features of the clavicle of Australian Aboriginal. Am J Phys Anthropol 1959;17:217-26. 46. SPSS Student Version 16.0 for Windows, SPSS Science Inc. Chicago;2004. 47. Kanchan T, Menezes RG, Moudgil R, Kaur M, Kotian MS, Garg RK, Stature estimation from foot length using universal regression formula in a North Indian population. J Forensic Sci 2010;55(1):163-66. 48. Lettre G. Genetic regulation of adult stature. Curr Opin Pediatr 2009;21(4):515-22. 49. Kondo S, Eto M. Physical growth studies on Japanese-American children in comparison with native Japanese, In: Horvath SM, Kondo S, Matsui H. Oshimura HY, editors. Human adaptability: Comparative studies on Human Adaptability of Japanese, Caucasians and Japanese Americans, Tokyo: Tokyo Press; 1975,13-46. 50. Meadows I, Jantz RL. Allometric secular change in the long bones from the 1800’s to the present. J Forensic Sci 1995;40(5):76267. 51. Pelin C, Duyar İ. Estimating stature from tibia length: a comparison of methods. J Forensic Sci 2003;48(4):708-12. 52. Ruff C. Variations in human body size and shape. Ann Rev Anthropol 2002;31:211-32.

59. Jit I, Kulkarni M. Times of appearance and fusion of epiphysis at the medial end of the clavicle. Ind J Med Res 1976;64:773-82. 60. Webb PO, Suchey JM. Epiphyseal union of anterior iliac crest and medial clavicle in a modern multiracial sample of American males and females. Am J Phys Anthropol 1985;68(4):457-66. 61. Kreitner KF, Schweden FJ, Riepert T, Nafe B, Thelen M. Bone age determination based on the study of the medial extremity of the clavicle. Eur Radiol 1998;8(7):1116-22. 62. Rogers NL, McCormick WF. A test of sex estimation using length and circumference measurements of the human clavicle on modern and archaeological samples (abstract). Am J Phys Anthropol Suppl 1997; 24:199. 63. Zwiesigk P, Schiborr M, Schmidt S, Schmeling A. Ultrasound studies on the time course of clavicular ossification. Int J Leg Med 2008; 122(2):163-67. 64. Schaefer MC. A summary of epiphyseal union timings in Bosnian males. Int J Osteoarchaeol 2008;18(5):536-45. 65. Kellinghaush M, Schulz R, Vieth V, Schmidt S, Schmeling A. Forensic age estimation in living subjects based on ossification status of the medial clavicular epiphysis as revealed by thin slice multi-detector computed tomography. Int J Leg Med 2010;124(2):149-54.

53. Gray JP, Wolfe LD. Height and sexual dimorphism of stature among human societies. Am J Phys Anthropol 1980;53(3):441-56.

66. Langley-Shirley N, Jantz RL. A Bayesian approach to age estimation in modern Americans from the clavicle. J Forensic Sci 2010; 55(3):571-83.

54. Black S, Scheuer B. Age changes in the clavicle: from the early neonatal period to skeletal maturity. Int J Osteoarchaeol 1996; 6(5):425-34.

67. Rios CG, Arciero RA, Mazzocca AD. Anatomy of the clavicle and coracoid process for reconstruction of the coracoclavicular ligaments. Am J Sports Med 2007;35(5):811-17.

55. Corrigan GE. The neonatal clavicle. Biol Neonatorum 1960;2(2):79-92.

68. Terry R. The clavicle of the American Negro. Am J Phys Anthropol 1932;16:351-79.

56. Basmajian JV. The surgical anatomy and

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71. Mohanty NK. Prediction of height from percutaneous tibial length amongst Oriya population. Forensic Sci Int 1998;98(3):13741. 72. Hauser R, Smolinski J, Gos T. The estimation of stature on the basis of measurements of femur. Forensic Sci Int 2005;147(2-3):18590. 73. Celbis O, Agritimis H. Estimation of stature and determination of sex from radial and ulnar bone lengths in a Turkish corpse sample. Forensic Sci Int 2006;158(2-3)135-39. 74. Petrovecki V, Mayer D, Slaus M, Strinovic D, Skavic J. Prediction of stature based on radiographic measurements of cadaver long bones: a study of the Croatian population. J Forensic Sci 2007;52(3):547-52. 75. Agnihotri AK, Purwar B, Googoolye K, Agnihotri S, Jeebun M. Estimation of stature by foot length. J Forensic Leg Med 2007; 14(5):279-83. 76. Musgrave JH, Harneja NK. The estimation of adult bone stature from metacarpal bone lengths. Am J Phys Anthropol 1978; 48(1):113-19. 77. Galloway A. Estimating actual height in the older individual. J Forensic Sci 1988; 33(1):126-36. 78. Giles E, Hutchinson DL. Stature and agerelated bias in self-reported stature. J Forensic Sci 1991;36(3):765-80. 79. Giles E. Corrections for age in estimating older adults’ stature from long bones. J Forensic Sci 1991;36(3):898-901. 80. Benazzi S, Orlandi M, Gruppioni G. Technical note: Virtual reconstruction of a fragmentary clavicle. Am J Phys Anthropol 2009; 138(4):507-14.

Volume 2 - Number 1 - 2011

BioCRA

Technical note

Sinus Physiolift: a new technique for a less invasive great sinus augmentation with crestal approach Rosario Sentineri DDS, MD¹* Giorgio Dagnino DDS¹

Aim The purpose of this article is to present an innovative surgical technique that produces a big maxillary sinus lift by the crestal approach through the use of hydrodynamic pressure for detaching the Schneiderian membrane. Materials and Methods Specific hollow elevators were designed, which due to their specific shape enable a closed system and exploits the Pascal’s principle of the incompressibility of liquids. With a micrometric device the physiological liquid was injected into the sub- Shneiderian space in order to detach the membrane. Results This Sinus Physiolift technique uses piezoelectric surgery to reduce the percentage of perforations of the sinus membrane compared to traditional drills and osteotomes. Conclusions This technique significantly reduces the risk of perforation of the membrane when compared to previous methods, but the most important benefit is a much less debilitating postoperative phase for the patient. In addition, the simplicity of the procedure reduces stress for the patient as well as the surgeon’s discomfort. (J Osteol Biomat 2011;1:69-75)

Keywords: sinus lift, hollow elevators, Sinus Physiolift, bone graft

¹Private practice, Genoa, Italy Corresponding author: *Rosario Sentineri Piazza De Ferrari 4/15 Genoa, Italy Tel. +390102474533 e-mail: rosario.sentineri@gmail.com

INTRODUCTION The insertion of implants in the posterior maxilla is often complicated by the presence of inadequate quantity and quality of bone. Among the various surgical procedures proposed to overcome the anatomic limitations of this area, the technique of sinus grafting with autologous bone or bone substitutes has proven to be a safe method with high predictability of success1-5. Access osteotomy which elevates the sinus membrane can be performed through a vestibular approach or a crestal approach. The main advantage of a crestal approach is the lower level of invasiveness when compared to a vestibular approach, which, though presenting the advantage of having a visual inspection of the separation, creates great discomfort to the patient undergoing surgery in the post-operative phases. The short and long term results of the sinus ridge augmentation have been shown in various studies. They show a high success rate with various morphologies and lengths of the implants, with many different surgical techniques and grafting materials. A minimally invasive surgical approach through the crest was proposed by Tatum in 1986 6 and subsequently refined by Summers in 19947-8-9. Depending on whether either the new

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bone is created with the preparation of the osteotomy site or graft material used, we have the OSFE technique (osteotomies Sinus Floor Elevation) or the BAOSFE technique (Bone-Added Osteotome Sinus Floor Elevation). Despite the lack of controlled studies for comparison between the implant site preparation with osteotome or drill, it seems that the osteotome technique significantly improves the success rate of implants in the posterior maxillary over the use of drills 10. Many authors adjust this technique with the intention of avoiding perforation of the membrane 11-14 and to use most of the remaining bone to ensure the position of the implant at the same time. Evidence relate to early failures in the majority of implants using this common technique of single-stage sinus lift during the healing period. The failures are correlated with smoking, occlusal overload, lack of primary stability, and a low residual bone height. If the ridge has a height less than 5mm does not ensure the primary stability of the implant, use of a delayed protocol of implant placement is necessary. In fact, it is recommended to avoid inserting implants at the same time in cases where there is residual bone height is less than 5 mm. The patient, however, must be subjected to at least two surgeries. With the crestal approach, the elevation of the muco-periosteal flap is often confined to the ridge, thus limiting damage to the vascular contribution of the lateral wall of the sinus. Numerous studies demonstrate the low incidence of perforation of the membrane, low incidence of pathologic alterations of the sinus mucosa and low incidence

Journal of Osteology and Biomaterials

of sinus infections respect to those reported with the lateral approach15. With the crestal osteotome technique, even if proven to be one of the most predictable, has a negative aspect, the use of the hammer cannot guarantee an optimal control of force and the discomfort of the patient. The use of drills significantly reduces the need to use the hammer, but this approach results in significant bone loss during the preparation of the implant sites. The Piezoelectric速 bone cutting technique was introduced in the year 200016 and its peculiarities of selective cutting can

Figure 1. CT shows a low bone quantity

reduce the rate of membrane perforation by 7% 17-18. This technology has permitted the development, in recent years, of a sequence of piezoelectric implant site preparations19 with inserts which reaches, through a crestal approach, the sinus membrane without the use of trephine drills or traditional drills presenting a high-risk of perforation. Since 2003 various techniques have been designed with the aim of raising the membrane through the use of an elastic balloon inflated by hydraulic pressure20-22. Although several studies show a high success rate, one of

Sentineri R. et al.

Figure 2. Intraoral x-ray

the complications of this method may be the rupture of the balloon, which may lead to a possible simultaneous rupture of the membrane. Some authors have recently proposed the use of techniques of sinus floor elevation using hydrodynamic pressure but none have guarantee a closed system23-25. Bassi and Lopez in 2010 26 developed a system which can elevate the Schneiderian membrane with a hydraulic detachment using a crestal approach. The purpose of this article is to present a new technique of detaching the sinus membrane and to obtain a big sinus lift, with the use of special hollow hydrants in the case of a height of at least 3 mm between the crown margin of the bone crest and the sinus floor, and the use of hydrodynamic pressure in combination with bone grafts. SURGICAL Technique Surgical case The female patient was 64 years and a non-smoker. Her medical condition was good. She presented a unilateral dental edentulia in the distal quadrant

Figure 3. IM1 and IM2P Piezoelectric site preparation.

Figure 4. Erosion of the cortical basal with OT9 insert.

2. The residual bone height below the maxillary sinus was very low as shown by CT and intraoral x-ray (Fig 1-2). She underwent 2 sessions of professional hygiene in the weeks prior to surgery. An antibiotic coverage was begun with amoxicillin clavulanic acid ,1capsule every 12 h for 6 days from the day before surgery, and 0.12% chlorhexidine rinse 2 times a day was administered. The patient underwent conscious sedation and pain control therapy with the following drugs: - cortisone (4 mg Bentelan) - benzodiazepines (diazepam, 1 mg boluses to achieve the effect) -NSAIDs (ketorolac tromethamine 1 vial during surgery) - Fargan - local anesthetic, mepivacaine with a 1:100,000 adrenaline ratio (Septanest 4% Septodont). A crestal incision distal to the 2.5 element was performed. The dissection of the total thickness of the flap was performed only on the bone crest. After bone exposure of the ridge, the first implant tunnel was prepared in the 2.7

position with Piezosurgery ® III (Mectron Piezosurgery, Mectron, Carasco, Italy). The ‘Bone’ power was set following the protocols designed by Dr. T. Vercellotti, mainly with regard to the initial steps with IM1 insert and then with IM2P insert up to one millimeter from the sinus floor (Fig 3). The baseline cortical sinus was eroded with a specific piezoelectric insert (Ot9 - Fig. 4) in order to obtain an access hole of 2.4 mm in diameter. The first hollow elevator was thus added by an implant micromotor (20 Ncm, 20 rpm) in the prepared site as far as the basal cortical area (Figs. 5-6). However, it was not necessary to penetrate the inside section of the sinus. The hydrant was stable in order to ensure watertight integrity. Once the hydrant was inserted, the Physiolifter® had to be connected, which joined the syringe containing a know volume of physiologic saline (Fig. 7). The hydrant was connected to the rubber hose which created a very effective pressure system, avoiding loss of pressure for separation, or lateral loss, in

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Figure 5. Insertion of the first hollow screw.

Figure 7. Physiolifter.

case of oval preparation or lack of firmness of the operator’s hand, or error in the techniques for the preparation site. It is worthwhile to remember that the syringe was filled before it was connected to the hydrant to avoid air bubbles. After checking for leaks for incorrect insertion of the hydrant, by pressing the Physiolifter®, the physiological liquid was injection in the sinus.

Journal of Osteology and Biomaterials

Figure 6. X ray control of the correct insertion of the first hollow screw

The membrane thus gradually became separated. Following this, a second implant tunnel was prepared in the 2.6 position and the steps were repeated in order to insert a second hollow hydrant (Figs. 8-9) The Physiolifter® was connected and the physiological liquid was injected for a second time. During this procedure the first hollow screw had a special airtight seal to ensure that the system was closed during the second elevation. (Fig. 10) The Physiolifter® tube was later disconnected and the Valsalva maneuver was performed on the patient in order to drain the isosaline liquid from the maxillary sinus. This maneuver was also performed to verify the integrity of the membrane. After the hollow hydrant was unscrewed, heterologous bone was compacted into the hole. Without any need to activate the pedal, by means of insert Ot9, the graft material that remained in the implant site was pushed into the sinus. If the graft material resisted, one possible way of op-

erating more easily consisted in intermittently activating the machine with the regulation of the physiological flow being as low as possible. After freeing the channel implant, conical implants (3,25 x 10 and 4 x 10 Full Osseotite, 3i Implant Innovations) were inserted according to need and using the submerged technique (Fig. 11). Prostethic phase and evaluation of the rise After 4 months of healing from surgery abutments were inserted and after 2 weeks two metal-ceramic crowns were screwed in the implants. The x-ray showed an accurate fit between implant and prosthesis and a satisfactory stability of the rise (Fig. 12) Discussion Since their introduction the maxillary sinus has always limited the placement of osseointegrated implants, and a growing need to overcome this anatomic limit with a stable solution, and at the same time, obtain a reduced cost

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Figure 8. Insertion of the second hollow screw.

Figure 9. X ray control of the correct insertion of the second hollow screw.

Figure 11. X ray control of the implants at baseline.

Figure 10. Airthight seal inserted.

Figure 12. X ray control after 4 months at an half.

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is now clear. Presenting the patient with the option of making a removable prosthesis is an easy, but obsolete solution in the implant era. Although removable prostheses are relatively easier to produce patients have a difficult time socializing and accepting the prosthesis. In an effort to resolve the psychological discomforts that removable prostheses may evoke in patients, dental surgeons now have the option of suggesting osseointegrated implants. There are many methods for lifting the sinus. Some have reached a very high predictability, as well as ease of performance that they can become part of a surgeon’s ordinary activity. The vestibular approach to the sinus on the one hand produces a “non-blind” approach and it is therefore easier to achieve good results. On the other hand, it causes a very debilitating period after surgery. Until recently this was considered to be the only way to produce a big sinus lift because the crestal approach in most cases does not allow an extended lift. This approach is certainly less disabling, but, as has already been mentioned, it does not allow good visibility of the operating area, which must therefore be perceived only instrumentally and requires great sensitivity. Traditional techniques cause much discomfort to the patient, for example, fracture of the sinus floor, or rising and compaction of any graft material inevitably require osteotomes which are “hammer and chisel” procedures, definitely not pleasant to the patient and cannot be controlled by the surgeon. The gold standard that must be reached must produce minimal discomfort to the patient . Along with this there must

Journal of Osteology and Biomaterials

also be the possibility of obtaining a large volume increase to generate more bone. A good technique was introduced with to the water balloon system, although an incomplete method, it is not completely controllable by the clinician because of the elastic resistance of the balloon, which does not permit a safe elevation of the sinus membrane. The Bassi & Lopez method 26 is similar to the method proposed here, since it uses the same hydraulic technique for elevating the sinus membrane and producing the sub-antral graft filling space. The main difference with the technique proposed in the present paper is in the preparation of the access route to the sinus that uses advantageously a piezoelectric site preparation saving the Schneiderian membrane 17-18 and the use of hollow screws instead of hollow cylinders to warrant a predictable pressure maintenance during all the elevating procedures, avoiding the risk of detachment of the hydrant from the crestal bone tunnel. The advantages may be: a better stabilization of the hydrant and no pressure losses during the detaching procedure. In the case of a lower height of the crestal bone, the use of screwed hydrants is more favourable since it maintains pressure and a predictable detachment of the membrane. To ensure the tightness of the system a special hollow screw was designed that, through an intimate contact achieved between the coils and the basal cortex, allows to use the pressure-tube syringe contained in the system optimally and efficiently.

Conclusions The level of lift in our system is much greater than other techniques which use the crestal approach. The most important benefit of this technique is the achievement of a much less debilitating postoperative period for the patient. To this we must add that less time is spent in the chair and the surgeon’s operative stress is also reduced. Considering that the operator was an experienced surgeon these results are very encouraging.The learning curve should progress very gradually, as the technique depends on the operator. However, a longer follow up is necessary in order to assess the stability of the lift. Acknowledgements We thank Mectron for collaborating and the production of the hollow elevators. We also thank 3i Implant Innovations Biomax Italy for the supply of implants.

Sentineri R. et al.

REFERENCES 1. Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg 1980;38:613-616. 2. Hirsch JM, Ericsson I. Maxillary sinus augmentation using mandibular bone grafts and simultaneous installation of implants. A surgical technique. Clin Oral Implants Res 1991;2(2):91-6. 3. Fugazzotto PA. Report of 302 consecutive ridge augmentation procedures: technical considerations and clinical results. Int J Oral Maxillofac Implants 1998;13(3):358-68. 4. Fugazzotto PA, Vlassis J. Long-term success of sinus augmentation using various surgical approaches and grafting materials. Int J Oral Maxillofac Implants 1998;13(1):52-8. 5. Kahnberg KE, Ekestubbe A, GrĂśndahl K, Nilsson P, Hirsch JM. Sinus lifting procedure. I. One-stage surgery with bone transplant and implants. Clin Oral Implants Res 2001;12(5):479-87. 6. Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986; 30:207-29. 7. Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium 1994a;15:152-160. 8. Summers RB. The osteotome technique. Part 3 - Less invasive methods of elevating the sinus floor. Compendium 1994b;15: 698-708. 9. Summers RB. The osteotome technique: Part 4- Future site development. Compendium 1995;16:1090-09. 10. Zitzmann NU, SchĂ¤rer P. Sinus elevation procedures in the resorbed posterior maxilla. Comparison of the crestal and lateral approaches. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1998;85(1):8-17. 11. Fugazzotto PA. The modified trephine/ osteotome sinus augmentation technique: technical considerations and discussion of indications. Implant Dent 2001;10:259-264. 12. Malchiodi L. Chirurgia implantare. Edizioni Martina Bologna. 2003;219-225.

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17. Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent 2001;21:561-567. 18. Wallace SS, Mazor Z, Froum SJ, Cho SC, Tarnow DP. Schneiderian membrane perforation rate during sinus elevation using piezosurgery: clinical results of 100 consecutive cases. Int J Periodontics Restorative Dent 2007;27:413-419. 19. Vercellotti T. Essentials in piezosurgery; clinical advantages in dentistry. Quintessence Pub. Co 2009 20. Muronoi M, Xu H, Shimizu Y, Ooya K.Simplified procedure for augmentation of the sinus floor using a haemostatic nasal balloon. Br J Oral Maxillofac Surg 2003;41: 120-121. 21. Soltan M, Smiler DG. Antral membrane balloon elevation. J Oral Implantol 2005;31: 85-90. 22. Hu X, Lin Y, Metzmacher AR, Zhang Y. Sinus membrane lift using a water balloon followed by bone grafting and implant placement: a 28-case report. Int J Prostho-

Volume 2 - Number 1 - 2011

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