JOB - Vol.2 N.3 - 2011

ISSN: 2036-6795

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Journal Journal of of Osteology Osteology and Biomaterials Biomaterials and

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147

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 Editors 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 Ahmed M. Osman Scientific Director Paolo Trisi Secretary Faten Ben Amor

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 Paulo Rossetti, Saint Paul, Brasil 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) and SENAME Societies. The Journal is published three times a year, one volume per year, by TRIDENT APS, Via Silvio Pellico 68, 65123 Pescara, Italy.

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149

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

contents

151

Review

Survival rate of implants in maxillary sinus augmented by means of anorganic bovine bone: a systematic review Francesca Pegna, Mario Bonino, Ivano Conti, Giovanni De Vico, Corrado Agrestini, Alberto Barlattani

Original articles

of a new nano-coating on implant osseointegration: 159 Evaluation a study on spiral fixtures inserted in New Zealand white rabbits Matteo Danza, Antonio Scarano, Annalisa Palmieri, Francesca Farinella, Ambra Girardi, Alessandra Lucchese, Francesco Carinci

and morphological properties of current 167 Physico-chemical Particulate biomaterials used in alveolar bone augmentation: a review.

France Lambert, Pierre Layrolle, Eric Rompen, Peter De Coster

177

Volar plate fixation of distal radius fractures: 3 years follow-up Vincenzo Sollazzo, Vincenzo Lorusso

183

Case report

Implant-retained prosthesis in a patient affected by von Recklinghausen’s Neurofibromatosis 1: a case report Saverio Capodiferro, Nunzio Francesco Testa, Carlo Lajolo, Eugenio Maiorano, Gianfranco Favia

Volume 2 - Number 3 - 2011

BioCRA

151

Review

Survival rate of implants in maxillary sinus augmented by means of anorganic bovine bone: a systematic review.

Francesca Pegna1*, Mario Bonino1, Ivano Conti1, Giovanni De Vico1, Corrado Agrestini1, Alberto Barlattani1

Aim: The efficacy of Anorganic Bovine Bone (ABB) as a graft material for sinus floor elevation was due to osteoconductive properties with no inflammatory or adverse responses. ABB alone or mixed with autologous bone (AB) or Demineralized Freeze-dried Bone Allograft (DFDBA) are used regularly as a biomaterial in the sinus lift procedures.

The objective of the present study was to evaluate the survival rate of implants in maxillary sinus augmented by means of ABB. Material and Methods: All prospective studies published from 1998 to 2010, in which sinus elevation was performed by means of ABB, were analyzed to conduct a systematic review. Inclusion criteria was: human studies with a minimum of 10 participants and a minimum follow-up period of 1-year after loading in which less than 5mm of alveolar crestal bone was needed for sinus augmentation. Smoking and controlled diabetes patients were also included. Results of separate data of ABB alone and ABB mixed with AB or DFDBA were included.

Results: From 1376 articles reviewed, 46 titles were screened and only 13 fulltext publications were identified as fulfilling the inclusion criteria. In all studies the investigation was carried out performing monolateral or bilateral maxillary sinus augmentation by means of ABB alone or ABB mixed to AB or DFDBA. A total of 1351 implants were positioned; the survival rate was 97.01% for ABB, 97,37% for ABB mixed to AB and 94,5% for ABB mixed to DFDBA, evaluated in a time between 6 and 8 months after grafting.

Conclusions: Maxillary sinus augmentation to facilitate immediate implant placement or in a second-stage procedure is an accepted method for areas of the posterior maxillary in which bone height is inadequate and implant stabilization is not likely. This study determined that ABB is a grafting material with osteoconductive properties and supports new bone formation, which indicates that the material takes part in the remodelling process. It is suggested that ABB provides excellent stability and osseointegration of implants with low probability of failure.

(J Osteol Biomat 2011; 3:151-157)

Key Words: dental implants, bone regeneration, sinus lift, bone substitutes, biooss, DBBM, xenograft.

1

Department of Stomatology, UniversitĂ Tor Vergata, Rome

Correspondence to: * Dr Francesca Pegna Via Aldo Moro, 36 00040 Pomezia, Rome, Italy e-mail: francesca.pegna@libero.it

INTRODUCTION Sinus floor augmentation is a highly successful and predictable procedure to increase bone volume for implant placement in the partially to severely atrophic maxilla1,2,3,4 ; a lateral maxillary osteotomy and grafting of osteoconductive materials, performed to increase the maxillary sinus has become a very popular procedure in the last few years, with predictable results5.

(Fig. 1,2,3). In contrast to this more invasive lateral approach, to augment bone for implant placement in a simpler, less invasive manner, Summers proposed the osteotome technique.

This method uses an internal sinus lift, which is performed using sequentially sized osteotomes to fracture the residual alveolar bone crestal to the sinus floor (Fig. 4,5,6).

Adverse conditions of the alveolar crest atrophy disease, a height of an alveolar ridge less than 5mm, may lead to insufficient vertical bone size or unfavourable jaw connection such as to preclude the incorporation of an endosseous implant or compromise the aesthetic and functional outcome of implant rehabilitation6 .

In recent years, the increasing demand of oral implant-supported rehabilitation led the implant research to focus

Volume 2 - Number 3 - 2011

152

Pegna F. et al.

its attention on endosseous component to obtain optimal results with minimum cure time7. The presence of adequate bone volume is a prerequisite for success in the medium and long term outcome of implants8,9 . Therefore, studies on biomaterials has been increasing exponentially in terms of the need to address and remedy the adverse and unfavourable anatomy of the implant site in order to obtain and maintain a good primary stability of the fixture2,7,10 . There are numerous materials available for the treatment of bone defects of the dentulous atrophic ridges including autologous bone grafts, homologous (demineralized freeze-dried bone allograft), heterologous bone grafts (mineral purified bovine bone) and synthetic materials (hydroxyapatite, beta-tricalcium-phosphate etc..). In spite of the autologous bone as the gold standard for grafting material in bone reconstructive surgery, the key to the success of any bone graft is primarily determined by the degree of vascularization4,11,12 .

Depending on the type of graft used, the cellular reactions that are produced within the bone structure are essentially of three types: Osteogenesis, osteoinductive and osteoconductive capacity. The osteogenesis function occurs due to the presence in the grafted material of osteoblast progenitor cells, which directly induce the formation of bone mineralization: this type of regeneration can be achieved only through the insertion of autologous grafts because other types of grafts do not provide cells13,14,15,16 .

The validity of any graft material resides in the osteoconductive and oste-

Journal of Osteology and Biomaterials

Figure 1.

Figure 2.

Figure 3.

Pegna F. et al. 153

Figure 4.

Figure 5.

Figure 6.

oinductive ability to promote a revascularization, because the osteogenesis function is guaranteed of the residual bone6,15. The osteoinductive function is the ability to induce the transformation of mesenchymal totipotent cells to osteoblastic and condroblastic cells.

Instead, the osteoconductive property is the function of support given by a grafting material for new bone cells that while not stimulating the production of bone, provides the internal growth and the deposition of bone15,17 .

The aim of this study is to compare data reported in the literature concerning the excellent biocompatibility and good osteocondictive and osteoinductive properties of ABB as grafting material in maxillary sinus augmentation and review the survival rates of implants placed in grafted maxillary sinuses, based on clinical reports from 1998 to 2010.

Material and Methods -Criteria for considering studies for this review The basis of this review was represented by only the prospective studies published in English from 1998 to 2010.

The protocol of the present systematic review was set out with the following methods: search strategy, eligibility criteria for study inclusion, screening methods, data abstraction and data synthesis.

Exclusion criteria 1)Patients affected with congenital malformations, bone defects following ablation for tumor or osteoradionecrosis were excluded.

2)Patients with uncontrolled diabetes were excluded.

3)Non-English language publications were not included and also case reports and retrospective studies were excluded.

- Search method The search strategy incorporated searching of electronic databases (Medline) from 1998 to 2010. Key words used in the search included the following: “dental implants”, “osseointegrated implants”, “ intraoral implants”, “oral implants”, “implant supported prosthesis”, “transmucosal implants”, “immediate implant placement”, “delayed implant placement”, “augmented ridges”, “bone augmentation”, “bone regeneration”, “sinus lift”, “sinus augmentation”, “bone substitutes”, “heterologous bone”, “bio-oss”, “dbbm”, “xenograft”. This serach was limited to studies involving human subject. The collected articles were published in the journals: “Oral Surg Oral Med Oral Pathol Oral Radiol Endod”, “Clin Oral Implants Res”, “Int J Oral

Inclusion criteria 1) Only patients presenting with deficient edentulous ridges following atrophy have been taken into consideration.

2) Human studies with a minimum of 10 participants and a minimum followup period of 1- year after loading in which less than 5mm of alveolar crestal bone needed a sinus augmentation.

3)Smoking and controlled diabetes patients were also included.

4)Only studies that used ABB as graft material with or without autologous bone or DFDBA. 5)Survival rate of implants placed in the augmented sites were analyzed.

Volume 2 - Number 3 - 2011

Patiens

Smoking //

// // 52/ 54/ 52 59 54 50,1 59

51 50,1 57 51 57 57 57

11 30

70 16

30 20

70 97

20 13

97

12 13

51

105 12

15 51

105 20

15

20

Hassani (2009) Marchetti (2007)

Galindo-Moreno Lorenzoni (2008) (2007)

Marchetti(2007) (2007) Mangano

Galindo-Moreno Mannai (2006) (2007)

Mangano (2007) Stuart J. (2006)

Mannai (2006)

Zvi ArtziJ. (2005) Stuart (2006)

Stuart J. (2005)

Ziv ZviMazor Artzi (2004) (2005)

Valentini Stuart J. (2000) (2005)

Ziv Mazor(1997) (2004) Valentini

Valentini (2000)

Valentini (1997)

ABB+AB ABB+AB

ABB+AB ABB+AB

AB ABB+AB

ABB+AB

Grafting AB materials

Grafting materials

Journal of Osteology and Biomaterials - T.1= Time one ( Implants placement) - T.0 = Zero time (Stage surgical implant) - T.1= Time one ( Implants placement)

-ABB= Anorganic bovine bone

-AB=Autologous bone

< o = 5mm

da 1.1 a 3.1

< o<5mm = 5mm

da 1.1 /a 3.1

-AB=Autologous bone

28

20

105 28

20 64

<5mm 3,8mm

- T.0 = Zero time (Stage surgical implant)

ABB+ DFDBA

ABB+AB ABB+ DFDBA ABB

ABB ABB+AB

105 24

<5mm /

3,8mm <5mm

<5mm <5mm

3,5-5mm <5mm

/ <5mm

< 4,5mm 3,5-5mm

/ <5mm

< 3,8mm 4,5mm

/ <5mm

/

/

/

//

//

//

//

//

/

//

//

//

/ cm3 1,4-5,56

10,5-12,22 / mm

/ 1,4-5,56 cm3

10,5-12,22 mm

ridge/ height at T1 (mm)

ridge height / at T0 (mm) 3,8mm

ridge height at T1 (mm)

ridge height at T0 (mm)

-ABB= Anorganic bovine bone

No smoking

No/ smoking No smoking

No Smoking smoking

ABB+AB ABB+ AB

13 64

ABB+ ABB+AB DFDBA

13 97

ABB+ ABB+AB DFDBA 24 13

13

ABB ABB

97/

48

/ 25

11 48

15 25

11

Sinus 15 lift ( N°)

Sinus lift ( N°)

/ ABB+ Smoking ABBAB

/

No Smoking Smoking

ABB+AB No/ ABB Smoking Smoking ABB+AB / ABB+AB

Smoking /

//

/

/

/

15 16

Piattelli (2010) Lorenzoni (2008) /

/

11

Hassani (2009)

/

Age / (average)

Smoke /

Smoke

Patiens 15

Age (average)

Authos Piattelli (2010)

Table 1: clinical analisis Table 1. Clinical analysis.

Authos

6-10

6

A T. 0 6-10

6 6-10

A T.6 0

6,5-8 6-10

6 6,5-8

6,5-8 A T. 0

A T. 0 6,5-8

AAT.T.00

AAT.T.00

A T.4 0

A T./ 0

A T. 0 4

/

Implants A T. 0 placed (Monts)

Implants placed (Monts)

1

1

13

13

31

3/

1/

/ 10

/2

102

26

24

61

/

4

- T.S.= survival rate of implants

6,4

6

6 6,4

612

612

12/

12/

/ 3-6

12 /

24 3-6

12 12

246

126

6

6

Implants Follow/ 6 failed up (N°) toT0 (Months) 1 6

Implants Followfailed up (N°) toT0 (Months)

- T.S.= survival rate of implants

60

57

276 60

57 135

276 77

135/

77/

/ 314

50 /

263 314

140 50

263 62

52 140

20 62

52

Implants 20 (N°)

(N°)

Implants

98,3

98,24

97,8 98,3

98,24 97,8

97,8 98,7

90 97,8

98,7 96,8

90 96,8

96 96,8

99 96,8

95,7 96

99 95,2

98 95,7

96,4

95,2

98

(%)

T.S. 96,4

T.S. (%)

154 Pegna F. et al.

Pegna F. et al. 155

Maxillofac Implants”, “ J Implant Dent.”, “The International Journal of Periodontics and Restorative Dentistry”, “ Journal of Oral and Maxillofacial Surger”, “ International Journal of Oral and Maxillofacial Surgery”, “British Journal of Oral and Maxillofacial Surger”, “International Journal of Periodontics and Restorative Dentistry”, “Journal of the American Dental Association”, “Journal of Periodontology”, and “ Implant Dentistry”.

The search resulted in 1376 studies in total. Following the first stage screening of titles, 46 potentially relevant publications were identified. Independent screening of abstracts (second stage screening), of these 46 selected titles, 2 studies conducted on animals are excluded, 3 studies are conducted in vitro, in 2 items the bovine bone is not considered as grafted material and 3 articles the survival of implants is not reported. Then the 35 selected articles, only 13 full-text publications were identified as fulfilling the inclusion criteria.

-Selection criteria and data extraction The selection of titles and abstracts as well as by the of inclusion and exclusion criteria was carried out through: 1) Years of publication (from 1998 to 2010), 2) Type of study (only prospective study), 3) Details of the outcomes reported. Despite the search through the key words included regenerative interventions, articles that observed all the inclusion and exclusion criteria apply only to actions of bone grafts in maxillary sinus elevation.

-Surgical procedure Reconstruction interventions were performed under local anesthesia, recipi-

ent site preparation by maintaining a full-thickness flap was prepared at the antero-lateral wall of the sinus. The osteotomy was performed and runs of the cavity with graft materials (ABB alone and ABB mixed to AB or DFDBA), the semi-absorbable barrier was positioned for containment the initial material and subsequent surgical suture with access points in simple monolayer detached. Articles that have used ABB with autologous bone (AB) as graft materials a first step drawing of intraoral bone was performed. The positioning of the implants in some articles analyzed was made in the same time of the sinus surgery, in the other articles after a time between 4 and 10 months.

Sutures after 10-15 days are removed.

Results The literature search provided a total of 13 articles (starting from 1376 selected) concerning the ABB grafts with or without other graft materials in maxillary sinus procedure in association with implant placement. From the data extrapolated in a total of 475 patients, aged between 50 and 57 years, that have undergone bone regeneration interventions concerning sinus augmentation and grafting materials only 35 subjects received ABB alone as graft material, 407 patients ABB with autologous bone and 20 patients received ABB with DFDBA. In 13 patients sinus lift was performed twice; in one sinus ABB alone and ABB with DFDBA in the other sinus. A total of 468 sinus lift were performed from a height of the alveolar ridge between 1.1mm and 5mm. The number of implants were 1506, of which 1063 were placed in the first surgery, at the time of the graft,

Figure 7. Search stategy.

391 implants were positioned in a time period between 4 to 10 months, and for the remaining 52 implants the surgical time was not specified.

Discussions The present systematic review produced only 13 prospective study publications, each describing interventions to increase the sinus with bone grafts and placement of implants simultaneously or after the first surgery. Numerous experimental and clinical studies 1,3, 5,7,8,9,11,12,16 have shown that the survival rate of implants is, on average, 97.8%.

In this systematic review eight studies1,2,4,7,9,10,17,18 describes grafting ABB bone in combination with homologous bone, in only three studies 5,12,19 where ABB was used as graft material and in 1 study 19 ABB with DFDBA was used.

Only in one study 3 two interventions were carried out , in one sinus bio-oss alone was grafted and in the second sinus ABB with autologous bone was

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used. From an analysis of the literature considered in this review the survival rate of implants varied from 96% to 99% , the lowest values were shown in the articles in which the positioning of the implants was contemporary to the grafted bone, in particular 95,7% 2, 96% 12 , 96,8% 17 , 97,8% 18 . Indices of survival rate significantly higher than these were reported in the surgery in which the delayed placement of implants varies from 6 to 10 months: 96,8% after 6,5-8 months 3 ; 98,7% after 6 months 4 ; 97,8% after 6-10 months 1 and 98,24% after 6 months 5 . These results clarify that the survival rate of implants is best in implants grafted subsequently placed and also in grafts with ABB alone or in combination with autogenous bone, except in 1 study 16 where the survival rate is 98,3% after 6-10 months, contrary to data reported in the Stuart J. et al. article (Int J Perio Rest Dent. 2006) 3 where the survival rate is 90% after 6,5-8 months in grafting of bio-oss with DFDBA. Finally, in the two studies greater values of survival rate were obtained: 99% 7 in implant position at the time or after the graft and 98% 9 , but is not specified when the implants are placed.

Journal of Osteology and Biomaterials

Conclusions Maxillary sinus augmentation to facilitate implant placement immediately or in a second-stage procedure is an accepted procedure for areas of the posterior maxillary in which bone height is inadequate and implant stabilization is not likely. In this study it is evident that ABB is among the best grafting material with osteoconductive properties and support for new bone formation, which indicates that the material takes part in the remodelling process.

The results obtained in this systematic review clarify that the survival rate of implants is best in implants grafted subsequently placed and also in grafts with ABB alone or in combination with autogenous bone, with the exception of only one study 16 where the survival rate is similar to the survival rate with ABB alone or in combination with autogenous bone. It is suggest that ABB provides excellent stability and osseointegration of implants with low probability of failure.

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REFERENCES 1. Wallace SS, Froum SJ, Cho SC, Elian N, Monteiro D, Kim BS, Tarnow DP. Sinus augmentation utilizing anorganic bovine bone (Bio-Oss) with absorbable and non absorbable membranes placed over the lateral window: histomorphometric and clinical analyses. Int J Periodontics Restorative Dent 2005;25(6):551-9.

2. Marchetti C, Pieri F, Trasarti S, Corinaldesi G, Degidi M. Impact of implant surface and grafting protocol on clinical outcomes of endosseous implants. Int J Oral Maxillofac Implants 2007;22(3):399-407.

3. Pettinicchio M, Traini T, Murmura G, Caputi S, Degidi M, Mangano C, Piattelli A. Histologic and histomorphometric results of three bone graft substitutes after sinus augmentation in humans. Clin Oral Investig 2010 [epub ahead of print].

4. Stuart J Froum, stephen S. Wallace, Ncolas Elian, Sang Choon Cho, Dennis P. Tarnow. Comparizon of Mineralized Cancellous Bone Allograft (Puros) and Anorganic Bovin Bone Matrix (Bio-Oss) for Sinus Augmentation: Histomosphometry at 26 to 32 Weeks After Grafting. Int J Periodontics Restorative Dent 2006; 26:543-551.

5. Artzi Z, Kozlovsky A, Nemcovsky CE, Weinreb M. The amount of newly formed bone in sinus grafting procedures depends on tissue depth as well as the type and residual amount of the grafted material. J Clin Periodontol 2005;32(2):193-9.

6. Valentini P, Abensur D, Wenz B, Peetz M, Schenk R. Sinus grafting with porous bone mineral (Bio-Oss) for implant placement: a 5-year study on 15 patients. Int J Periodontics Restorative Dent 2000;20(3):245-53.

7. Cawood JI, Howell RA. A classification of the edentulous jaws. Int J Oral Maxillofac Surg 1988;17(4):232-6.

8. Galindo-Moreno P, Avila G, FernándezBarbero JE, Aguilar M, Sánchez-Fernández E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res 2007;18(3):376-82.

9. Borges FL, Dias RO, Piattelli A, Onuma T, Gouveia Cardoso LA, Salomão M, Scarano A, Ayub E, Shibli JA. Simultaneous Sinus Membrane Elevation and Dental Implant Placement Without Bone Graft: A 6 Month

Follow-Up Study. J Periodontol 2011; 82(3):403-12.

10. Gutwald R, Haberstroh J, Stricker A, Rüther E, Otto F, Xavier SP, Oshima T, Marukawa E, Seto I, Enomoto S, Hoogendijk CF, Schmelzeisen R, Sauerbier S. Influence of rhBMP-2 on bone formation and osseointegration in different implant systems after sinus-floor elevation. An in vivo study on sheep. J Craniomaxillofac Surg 2010;38(8):571 9.

11. Valentini P, Abensur D. Maxillary sinus floor elevation for implant placement with demineralized freeze-dried bone and bovine bone (Bio-Oss): a clinical study of 20 patients. Int J Periodontics Restorative Dent 1997;17(3):232-41.

12. Hassani A, Khojasteh A, Alikhasi M, Vaziri H. Measurement of volume changes of sinus floor augmentation covered with buccal fat pad: a case series study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107(3):369-74.

1998;9(1):59-64.

19. Valentini P, Abensur D. Maxillary sinus floor elevation for implant placement with demineralized freeze-dried bone and bovine bone (Bio-Oss): a clinical study of 20 patients. Int J Periodontics Restorative Dent 1997;17(3):232-41.

20. Bilhan H, Geckili O, Mumcu E, Bozdag E, Sünbüloğlu E, Kutay O. Influence of surgical technique, implant shape and diameter on the primary stability in cancellous bone. J Oral Rehabil 2010;37(12):900-7.

21. Mannai C. Early implant loading in severely resorbed maxilla using xenograft, autograft,and platelet-rich plasma in 97 patients. J Oral Maxillofac Surg 2006;64(9):1420-6.

22. Mazor Z, Peleg M, Garg AK, Luboshitz J. Platelet-rich plasma for bone graft enhancement in sinus floor augmentation with simultaneous implant placement: patient series study. Implant Dent 2004;13(1):65-72.

13. Kirmeier R, Payer M, Wehrschuetz M, Jakse N, Platzer S, Lorenzoni M. Evaluation of three-dimensional changes after sinus floor augmentation wit different grafting materials. Clin Oral Implants Res 2008;19(4):366-72.

14. 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.

15. Mangano C, Scarano A, Perrotti V, Iezzi G, Piattelli A. Maxillary sinus augmentation with a porous synthetic hydroxyapatite and bovine-derived hydroxyapatite: a comparative clinical and histologic study. Int J Oral Maxillofac Implants 2007;22(6):980-6.

16. Chiapasco M, Ronchi P. Sinus lift and endosseous implants--preliminary surgical and prosthetic results. Eur J Prosthodont Restor Dent 1994;3(1):15-21.

17. Chiapasco M, Ferrieri G, Rossi A, Senna A, Accardi S. Rialzo del seno mascellare a scopo implantologico. Implantologia Orale 2001:2;22-46.

18. Valentini P, Abensur D, Densari D, Graziani JN, Hämmerle C. Histological evaluation of Bio-Oss in a 2-stage sinus floor elevation and implantation procedure. A human case report. Clin Oral Implants Res

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Original article

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Evaluation of a new nano-coating on implant osseointegration: a study on spiral fixtures inserted in New Zealand white rabbits Matteo Danza1, Antonio Scarano1, Annalisa Palmieri2, Francesca Farinella2, Ambra Girardi3, Alessandra Lucchese MD2, Francesco Carinci MD2*

Purpose: Titanium is the gold standard among materials used for prosthetic devices because of its good mechanical and chemical properties. When exposed to oxygen, titanium becomes an oxide that is biocompatible and able to induce osseointegration. There are three allotropic forms of titanium dioxide: brookite, rutile and anatase. Anatase can be prepared as a colloidal suspension and then used to coat surfaces. Anatase coating (AC) can potentially have specific biologic effects.

Materials and Methods: We tested the effect of AC on bone in an in vivo study by using spiral dental implants covered with AC and then inserted in rabbit tibia.

Results: The histologic analysis has demonstrated that (1) bone growth is equal around AC and standard fixtures but (2) AC fixtures have an antibacterical propriety that protect implants from subsequent peri-implantitis.

Conclusions: This study demonstrates that the AC implant inserted in rabbit tibia guarantees good osseointegration of normal titanium implants providing an addition antibacterical propriety.

(J Osteol Biomat 2011; 3:159-165)

Key-words: Titanium, coating, osseointegration, implant, fixture

Dental Clinic, University of Chieti, Chieti, Italy Deptartment of D.M.C.C.C., University of Ferrara, Ferrara, Italy 3 Department of Histology, Embryology and Applied Biology, University of Bologna, Bologna, Italy 1 2

Corresponding author: Prof. Francesco Carinci, MD, DMD Department of D.M.C.C.C. University of Ferrara Corso Giovecca, 203 44100 Ferrara (Italy) Tel +39-0532-291582 Fax : +39-0532-291582 e-mail:crc@unife.it

INTRODUCTION A spiral implant is a conical internal helix implant with a variable thread design which confers the characteristic of self drilling, self tapping and self bone condensing. These proprieties offer better control during insertion and high initial stabilization even in poor quality bone. Small diameter drilling results in reduced trauma and minimal bone loss. Location and orientation of implant can be altered even after initial insertion without trauma to the surrounding tissues. Its advantages are particularly obvious in compromised situations where there is minimal amount of bone and low bone density, achieving high stabilization in freshly extracted sites and thin sinus floors without prior bone augmentation. The self drilling capability of the implant allows it to be inserted into sites that have been prepared to a reduced depth.

This ability becomes very useful in situations of close proximity to anatomical structures such as the mandibular nerve canal or the maxillary sinus and nose cavity.1-9 The spiral implant family (SIF) is composed of two types of implants, the Spiral Implant (SPI - Fig. 1) and

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the Spiral Flare Bevel (SFB - Fig. 2).

The latter one has a reverse conical head that permits an increased volume of crestal bone around the implant neck. That accounts for some additional benefit, such as a closer placement of adjacent implants without compromising health tissues and aesthetic outcome.1-9 Pure titanium and titanium alloys are materials widely used in orthopaedic and dental surgery because of their desirable mechanical properties, chemical stability and biocompatibility.10-17 Titanium is used to manufacture joint prosthesis for partial and total joint replacement.

Moreover, titanium is also used to produce plates and screws for osteosynthesis in fractures and dental implants to substitute lost teeth.14-26 The biocompatibility of titanium is closely related to the properties of the surface oxide layer, in terms of its structure, morphology and composition.13 Although titanium dioxide exists in three different crystal lattices, anatase, rutile and brookite, only anatase and rutile are produced commercially.12 Normally, on the surface of the prosthesis made of titanium there is a stochastic distribution of two titanium-oxides (rutile and anatase) which are responsible for the properties of the material.13 When we have a crystalline surface of only one type of titanium-oxide (rutile or anatase) we can expect the improvement of some properties of the titanium oxide in osseointegration. In biomedical implants, the anatase TiO2 phase shows an enhanced ability to

Journal of Osteology and Biomaterials

Figure 1- Spiral Implant (SPI)

Figure 2- Spiral Flare Bevel (SFB)

induce bone-like apatite in comparison with the rutile phase.18 Various physical and chemical treatments of the Ti surface have been proposed to obtain the most biocompatible implant surface.4-15 In this study we have focused our interest on the anatase allotrope titanium coating. In fact, anatase titanium polymorph can be prepared as a colloidal suspension (anatase coating - AC) and then used to coat surfaces to improve their characteristics.19, 27-31 Here we tested the biological effect of AC on bone by using an in vivo model: dental implants covered with AC and controls were inserted in rabbit tibia and then histologically analyzed to evaluate the effect of AC on bone.

tercline (WO/2008/020460 - see: http://www.wipo.int/pctdb/en/ wo.jsp?WO=2008020460).

Both coatings have a strong antibacterial activity.

MATERIALS AND METHODS Implants preparation of Bacterclin Anatase Coating (BAC) Implants were covered with two different layers: the first was based on a solution containing a benzalkonium chloride (BZ) the second a new anatase coating called Bac-

Animal model This study included a total of 9 implants (5.5mm in diameter by 10 mm in length) inserted in 3 New Zealand white rabbits. Three different surface groups were included.

The first group, Bactercline (BAC) (n=3). The second group presented a SLA coated surface (n=3) and were untreated Alpha Bio implants (Petach Tikva, Israel). The third group presented BZ coated surface (n=3) Both surfaces were previously characterized physico/chemically.

The project was conducted after approval of the local Ethical Committee for Human and Animal Studies.

Prior to surgery, the animals were sedated with a dose of ketamine (44mg/kg) (Ketalar, Parker Davis Spa, Milan Italy) and xylazine (6 to 8 mg/kg) (Rompum, Bayer AG

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Figure 3- The compact bone was present in the cortical area. Toluidine blue and acid fuchsin 12X

Figure 4 - Newly-formed bone is present in the direct contact of implant. Toluidine blue and acid fuchsin 100X

Figure 5- Mature bone was in direct contact with the implant surface in the cortical area, while, in other areas a trabecular bone was present around implant surface.

Toluidine blue and acid fuchsin 50X

Leverkusen, Germany). A local injection of 1.8 mL of lidocaine without vasoconstrictor (Lidocaine, Astra, Sodertalie, Sweden) was given.

A full thickness incision was made to expose the distal portion of the femur, and osteotomies were prepared with a 2.0 mm pilot bur used on a specially designed electric machine operated at 600 rpm with saline irrigation. The subsequent drilling was completed with slow speed sequential drilling with burs of growing diameter (3.5 mm). The implants were then inserted in the osteotomy sites without saline irrigation. The plateau form implants were placed 1 mm below the bone level according to the manufacturer’s instructions. Standard layer suture techniques were adopted with reabsorbable sutures for the internal layers (Vicryl 4.0, Ethicon, USA) and non-reabsorbable suture for the skin (Monocryl 4.0 Ethicon).

After the surgery a single dose of antibiotic was given intramuscularly (0.25 cefazolin , Teva Italia, SRL).

All rabbits were euthanized after 6

weeks with an overdose of Tanax T-61.

Histomorphometry was carried out using a light microscope (Laborlux S, Leitz, Wetzlar, Germany) connected to a high resolution video camera (3CCD, JVC KY-F55B, JVC®, Yokohama, Japan) and interfaced to a monitor and PC (Intel Pentium III 1200 MMX, Intel®, Santa Clara, CA, USA). This optical system was associated with a digitizing pad (Matrix Vision GmbH, Oppenweiler, Germany) and a histometry software package with image capturing capabilities (Image-Pro Plus 4.5, Media Cybernetics Inc., Immagini & Computer Snc Milano, Italy). The histomorphometric measurements involved the mean percentage of bone to implant contact (BIC).

Histologic analysis The implants and surrounding tissues were immediately stored in 10% buffered formalin and processed to obtain thin ground sections. The specimens were processed using the Precise 1 Automated System (Assing, Rome, Italy).

The specimens were dehydrated in a graded series of ethanol rinses and embedded in a glycolmethacrylate resin (Technovit 7200 VLC, Kulzer, Wehrheim, Germany). After polymerization the specimens were sectioned, along the longitudinal axis of the implants, with a high-precision diamond disc at about 150 mm and ground down to about 30 mm with a specially designed grinding machine. Three slides were obtained for each implant. These slides were stained with acid fuchsin and Toluidine blue and examined under a Leitz Laborlux transmitting light microscope (Leitz, Wetzlar, Germany).

Data analysis Statistical analysis was performed by one-way ANOVA. The Tukey’s post-hoc test was used for multiple comparisons. The level of significance was set to p<0.005.

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Figure 6- Woven bone with large osteocite lacune is present in central portion of implant. Toluidine blue and acid fuchsin 100X

Figure 7- Mature bone is present in the coronal portion of the implant, while, only a few and very small trabeculae are present in the central portion of implant. Toluidine blue and acid fuchsin 50X

Results All the animals remained in good health throughout the length of the experiment. At sacrifice, neither clinical signs of inflammation nor adverse tissue reaction were observed and all implants were stable.

Histomorphometry (Bone implant contact - BIC) The BIC values did not show significant differences between the two groups during all periods of observation. The one-way ANOVA results showed a significant effect of implant surfaces (p<0.05) and no effect of implantation time (p > 0.05).

Control The compact bone was present in the cortical area (Fig. 3), while in the other regions, the surface was lined by small trabeculae that

Journal of Osteology and Biomaterials

tended to surround the whole perimeter of the surface (Fig. 4). The newly-formed bone tended to grow into the small irregularities of the implant surface. A decreased osteoblast presence was observed.

No multinucleated giant cells and inflammatory cells were observed.

The BIC percentage was 65.0 ± 4.5 %.

BAC Mature bone was in direct contact with the implant surface in the cortical area (Fig. 5), while, in other areas a trabecular bone with osteoid matrix was present around the implant surface. The bone trabuculae is in direct contact with the implants (Fig. 6). A few osteoblasts were present in the area of contact of the implant surface. The BIC percentage was 62.0 ± 3.5 %.

BZ Histomorphologic analysis of the BZ implant surface revealed the formation of a thin layer of bone on the surface of the implant. In the cortical area compact mature bone with smaller marrow spaces were observed (Fig. 7). Newly formed small bone trabeculae growing towards the central implant surface was also apparent. (Fig. 8). A lesser quantity of osteoblasts was observed. No gaps were present between the bone and the implant surface. No multinucleated giant cells and inflammatory cells were present. The BIC percentage was 44.0 ± 5.5 %.

Danza M. et al.

Discussion The idea of surface modification is to retain the desired bulk properties while modifying only the outermost surface, which interacts with the surrounding tissues.11 Titanium which has been used since thirty years proved to be a good material for surgical application, such as for prosthesis for joint replacement and for dental substitution. Titanium is well tolerated by the bone and is able to induce osseointegration of the implant.

Recently titanium film has been used to cover prosthetic implants in medical applications such as orthopaedic or dental surgery.20 Titanium film on an active surface is able to improve the biocompatibility of titanium implants.18 In prosthesis made of titanium the titania film surface is mainly composed of two polymorphs of titanium, rutile and anatase. Rutile is considered as the stable form of titania while anatase is metastable and converts to rutile at high temperatures.18 Anatase titania is more advantageous for medical applications than rutile. Compared to rutile, anatase exhibits stronger interactions between metal and support, and the surface of anatase titania can absorb more OH- and PO43- than that of rutile titania in body fluid, which is in favour of depositing bone-like apatite.21, 22 In this study we tested in an in vivo model a coating of the implants with 2 nanomaterials: BZ and BAC. Particularly, we tested BAC to evaluate its effect on bone growth.

163

Figure 8- Newly formed small bone trabeculae were observed growing towards the central portion of implant surface. Toluidine blue and acid fuchsin 100X

The advantages of the use of a colloid solution to cover implants is evident if one considers that this procedure adds new proprieties to implant surfaces without modifying proprieties related to the macro- , the mini- and the micro-design. In fact, from a general point of view, it is possible to distinguish a macro-, a mini- , a micro and a nano-design of prosthesis. The macro-design is the shape of the prosthesis: some examples are offered by the cylindrical or root form of dental implants.

The mini-design is the dimension of threads or the shape of the neck of the dental fixture. The dimension range from 1 to 0.1 mm. The microdesign is the shape of the implant surface: an example is provided by the “grooves and holes” due to sur-

face treatments like machination, acid etched and sand blasted procedures. These treatments determine the roughness of the surface and the “holes” have a cellular dimension.

Finally, the nano-design is determined by the molecular composition of the surface. The possibility to have a colloid suspension to coat the prosthesis has the advantage of maintaining the proprieties related to the macro-, mini and micro-designs of the implant and to add new ones related to the nano-design.

This idea is supported by the presented data which show that BAC induced new bone formation in the peri-implant surface as well as induced by titanium control group.

On the contrary BZ surface – that

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also has antibacterial activity â&#x20AC;&#x201C; has an adverse effect on osseointegration.

The capacity to induce osseointegration is a crucial characteristic of a good prosthetic implant and it gives more chances of long term survival to the implant itself.32, 33 Moreover, osseointegration strongly depends on the characteristics of the surface of the material employed.16, 17, 23-25 In this study we have shown through an in vivo approach that an AC implant inserted in rabbit tibia guarantee a good osseointegration of normal titanium implants giving an addition antibacterical propriety. We conclude that AC can be a useful material to coat prosthetic devices to be inserted in bone tissue.

REFERENCE

Acknowledgments The authors declare that they have no financial relationship with any commercial firm that may pose a conflict of interest for this study.

This work was supported by grants from University of Ferrara, Italy (F.C.), Fondazione CARISFE (F.C.) and PRIN 2008 (F.C.)

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29. Sollazzo V, Palmieri A, Pezzetti F, Scarano A, Martinelli M, Scapoli L, Massari L, Brunelli G, Caramelli E, Carinci F. Genetic effect of anatase on osteoblast-like cells.

J Biomed Mater Res B Appl Biomater 2008;85:29-36.

30. Palmieri A, Pezzetti F, Brunelli G, Arlotti M, Lo Muzio L, Scarano A, Rubini C, Sollazzo V, Massari L, Carinci F. Anatase nanosurface regulates microRNAs. J Craniofac Surg 2008;19:328-33.

31. Scarano A, Piattelli A, Polimeni A, Di Iorio D, Carinci F. Bacterial adhesion on commercially pure titanium and anatase-coated titanium healing screws: an in vivo human study. J Periodontol 81:1466-71.

32. Kusakabe H, Sakamaki T, Nihei K, Oyama Y, Yanagimoto S, Ichimiya M, Kimura J, Toyama Y. Osseointegration of a hydroxyapatite-coated multilayered mesh stem. Biomaterials 2004;25:2957-69.

33. Frosch KH, Sondergeld I, Dresing K, Rudy T, Lohmann CH, Rabba J, Schild D, Breme J,

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Original article

Physico-chemical and morphological properties of current Particulate biomaterials used in alveolar bone augmentation: a review.

1

2

France Lambert DDS, MS, PhD , Pierre Layrolle PhD , 3 4 Eric Rompen DDS, MS, PhD , Peter De Coster DDS, PhD

The efficacy of grafting materials for alveolar bone regeneration procedures has been repeatedly corroborated by clinical and scientific evidence. Although an ever growing number of biomaterials are available on the market, the origins, material characteristics, bioactivity and osteoconductive properties of these products are not always known by clinicians, hence often hampering an adequate product selection. The purpose of this contribution was to provide an overview of five different types of osteoconductive grafting materials frequently used in dentistry (Bio-Oss®, Cerasorb M™, Bone Ceramic®, Natix®, Genos®) and to summarize their physico-chemical and morphological characteristics at the macro- and micro-scale. Furthermore, the influence of these properties on the in vivo behaviour of these biomaterials is discussed. The results of this study are presented as data sheets, which may prove helpful for clinicians in the design of their treatment strategies.

(J Osteol Biomat 2011; 3:167-175)

Keywords: Calcium phosphate, Biomaterials, physico-chemical properties, bone substitute.

1

Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, Belgium 2 Inserm U957, Faculty of Medicine, University of Nantes, Nantes, France 3 Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, Belgium 4 Department of Oral Biology, Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium Correspondence to *France Lambert, DDS, MS, PhD Service de Médecine Dentaire Domaine du Sart Tilman Bat B35 B-4000 Liège Belgium Phone: +32 43 668 290 Email: france.lambert@gmail.com

INTRODUCTION Alveolar bone engineering techniques are frequently used in periodontal therapy as in oral and maxillofacial surgical procedures with effective clinical outcomes.1-3 Although autogenous bone has long been regarded as the gold standard for bone augmentation procedures, supplying osteoinductive growth factors, osteogenic cells, and a structural scaffold,4 it may present considerable disadvantages, such as a limited availability and a high morbidity risk at the donor site. For these reasons, biomaterials have been developed as promising alternatives for autogenous bone,5-7 and both natural and synthetic materials are increasingly being used for filling bone defects.8-16 Although natural osteoconductive biomaterials such as porcine and bovine xenografts are currently used on a large scale because of their similarity to human bone regarding chemical composition and structure,17-19 the interest in synthetic grafting materials has been increasing for ethical reasons. These products of synthetic origin are being developed at a growing pace with the objective of fabricating biomaterials that mimic the extracellular matrix of bone, not only with respect to the chemical composition but also to its structural and functional properties.20

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168 Lambert F. et al.

Figure 1. Overview of physical biomaterial characteristics at different scales

Calcium phosphate-based particulate teogenic cells with the biomaterial sur- At last, the above biomaterials used scaffolds materials currently come in face.24, 25 The particle size, for instance, in bone regeneration procedures are Fig. 1: Ca/P Overview of physical biomaterial characteristics at different scales varying ratios displaying different available in different forms, such as appears not only to affect the contact rare. In conclusion, comprehension of the particles, influence of material characteristics its in vivo solubility rates in physiological condi- area powders, blocks, oncements but also thea detailed packing characteristions, in decreasing order ranging from tics or grafting even hydrated Since macof the material, behavior is crucial for theultimately clinician to deterdecide which material to pastes. use for preservation or calcium tetraphosphate (Ca4 P2 O9) to mining the interconnecting macropo- rostructural properties, however, may regeneration of the alveolar bone. In this context, accessibility of the physico-chemical data via a set of anhydrous dicalcium phosphate, tri- rosity of the particle ensemble (crucial considerably influence handling during calcium phosphate (Ca 3 (PO4)2), and for product data regeneration). sheets may represent a helpful tool to theclinical decision procedures, process. the physical form bone Additionally, hydroxyapatite (Ca10 (PO4)6 (OH)2). recent studies have demonstrated that in which a material is delivered to the Previous studies showed that materi- microporosities significantly accelerate clinician may also have an important als with a low Ca/P ratio resorb more osseointegration.21, 24, 26-29 impact on osteogenesis, more in parrapidly, resulting in loss of mechanical TABLES AND FIGURES strength, whereas those with greater Table 1. Physico-chemical characteristics and related in vivo effects of calcium Ca/P ratios, such as hydroxyapatite, ap- phosphate based biomaterials.

Characteristic Definition In vivo effect(s) pear to be more stable and to degrade 21-23 more slowly.

Micro-­‐porosity Intraparticle space (<10 µm) Determines c ell a dhesion a nd proliferation However, the chemical composition Macro-­‐porosity Interparticle space (100-­‐500 µm) Allows invasion of cells and blood v essels, determines contact area for surface reactivity alone is by no means the only factor in determining the nature and extent of Particle density Sample mass / volume o f the solid Determines dissolution or r esorption rate scaffold biodegradation. Physical material characteristics such as crystallinity, Specific surface area Total surface in contact with body fluids Determines osseoinductive material capacities, determines dissolution or resorption rate crystal size, particle size, porosity and Crystalline phase Phase % of mineral Determines dissolution or r esorption rate surface roughness have additionally been reported to influence the biologiWater content Total content of water included or bound Determines initial material degradation cal performance of biomaterials. It is Organic material content Total content of protein material (eg.

Determines initial inflammatory host r esponse collagen) known that surface area and topogMineral content Total content of calcium phosphates Determines dissolution or r esorption rate, a llows raphy (mainly pore size) exert a major facilitation of c ell proliferation/attachment influence over the interaction of osTable I: Physico-chemical characteristics and related in vivo effects of calcium phosphate based

Journal of Osteology and Biomaterials

biomaterials.

Lambert F. et al.

169

Technologies AB, Malmö, Sweden; Genos®, Tecnoss Dental srl, Pianezza, Italy) were enrolled in order to compose a data sheet of their physico-chemical characteristics based on a set of different scales (Fig. 1). Macroscopic and microscopic analyses using digital photograpy and scanning electronic microscopy (SEM), respectively, were performed and additional data on physico­ chemical characteristics and their respective impact on neo-osteogenesis were extracted from the literature. All samples were obtained directly from the manufacturers in sealed vials and used without further treatment.

Macroscopic morphology analysis High magnification pictures were taken using a digital Nikon 200D camera and a 100 mm lens at the highest magnification. Furthermore, high magnification pictures (20X) were obtained using a binocular stereozoom (Zeiss, Germany).

Figure 2. Bio-Oss® data sheet ® Fig. 2: Bio-Oss ticular on celldata andsheet blood vessel coloni-

macromorphology, micromorphology and chemical composition. The overall sation of the substrate. objective was to compose a data sheet The main purpose of this contribufor each material of interest that could tion was to provide an overview of the be used by the dental practioner as an properties of a selection of commeridentity card of the material. cially available mineral-based biomaterials, which are frequently used as bone fillers in periodontal/oral surgery. 12 MATERIALS AND METHODS Five currently used calcium-phosphateThis goal was achieved by reviewing based biomaterials (Bio-Oss®, Geistlich the available literature dealing with physico-chemical characteristics of Pharma AG, Wolhusen, Switzerland; the biomaterials in focus. Each prodCerasorb M™, Curasan AG, Frankfurt, uct was consequently studied with reGermany; Bone Ceramic®, Straumann spect to the three following aspects: AG, Basel, Switzerland; Natix®, Tigran

Microscopic analysis Samples were placed on carbon conductive tape on cupper tabs and sputtered with platinum for 45 s. Scanning electron microscopy (SEM, JEOL 6400) observations were performed at the Institut des Matériaux de Nantes, Nantes, France. SEM pictures were taken using secondary electron mode at 7 keV with ascending magnifications : x200, x500, x1000, x2000, x5000.

Physico-chemical characteristics (review) Further characteristics such as macro-, micro- and total porosity as well as density and specific surface area were

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170 Lambert F. et al.

inter-particle spaces. The size of these voids, related to the way the particles are packed, depends on the particle size and shape as well as on the particle size distribution. The total porosity of the particles heap is calculated from the sum of the intra-granular microporosity and the inter-granular interstitial spaces (macro-porosities).

The particles density is the ratio: sample mass / volume of the solid.

The specific surface area (m2 g -1) is calculated as the total surface in contact with body fluids. This value directly depends on microtopography and microporosity.

The crystalline phases of the biomaterials indicates the chemical composition (presence of crystalline phases) and the amounts of impurities, which can increase the risk of foreign body reactions. The American Society for Testing and Materials requires a phase purity ≥ 95% (ASTM F1088-04).

Figure 3. Cerasorb M™ data sheet Fig. 3: Cerasorb M™ data sheet

ferent physico-chemical material characteristics in focus and their related effect/impact on bone regeneration at the cellular level. Micro-porosity corresponds to the voids of the particle themself defined as micropores or inRESULTS 13 The results are summarized for each traparticle spaces smaller than 10µm. studied biomaterial as a data sheet, Macro­porosity corresponds to pores in including manufacturer description the range of 100-500 µm in diameter and fabrication method, macroscopic allowing the invasion of cells, tissue morphology, microscopic morphology and blood vessels. Macroporosity also and chemical composition (Figs. 2-6) results from empty spaces between Table 1 gives an overview of the dif- the particles, commonly designated as extracted from physico-chemical characterisation studies present in the literature, if available or directly from the manufacturer.

Journal of Osteology and Biomaterials

DISCUSSION The physico-chemical characteristics of biomaterials used in bone grafting procedures can be evaluated at different scales, each of them having a distinct influence on osteogenesis. These characteristics are unique to the material and exclusively account for its in vivo behaviour in sites where high-quality neoosteogenesis is desired (Table I): i. Macroscopic morphology (milli scale, 10-3) Calcium-based biomaterials used in the dental field to promote bone preservation / regeneration exist in different forms, such as particles, powders, blocks, cements or hydrated pastes.

Lambert F. et al.

Figure 4. Bone Ceramic® data sheet Fig. 4: Bone Ceramic® data sheet

The particle size not only affects the contact area but also the packing characteristics of the materials, ultimately determining the macroporosity of the particle ensemble.26, 28 Although the ultimate biological response cannot be predicted, smaller particles (around 14 300 μm) appear to be the basis of a better performance.26, 28, 30 With respect to the effect of porosity on bone regeneration, however, controversy exists in literature. In order to induce bone growth, a mechanically stable

surface is needed avoiding micromotion caused by debris and loose particles.31, 32 ii. Microscopic morphology ( micro – nano scales; 10 -6 and 10 -9 resp.)

Previous studies confirm that surface area and scaffold architecture, mainly pore size and pore interconnectivity, exert a major influence over the interaction of osteogenic cells with the biomaterial surface.24, 25, 33 Although it is generally recognized that large pores (> 100 μm) enhance new bone forma-

171

tion33, it has been reported that microporosity can be used to accelerate osseointegration.24, 27, 29, 34 Moreover, it has been shown that nanoporous structures improve cell adhesion, proliferation, and differentiation.26 On the other hand, a compromise between porosity and mechanical performance of the scaffolds exists, whith higher porosity resulting in reduced mechanical strength.33, 35 Recent investigations also support the hypothesis that surface reactivity also plays a role in osteoinduction: on the surface of the material, a dissolutionprecipitation process takes place which is accompanied by co-precipitation of relevant endogeneous factors such as cytokines or proteins.32, 36 This specific property was previously found to be associated with specific geometry of the material37, 38, favorizing the binding of an optimum amount of endogeneous bone morphogenetic proteins (BMP) allowing the material to become osteoinductive. Previous authors specified in this context that bone is not induced below a certain low level of specific surface area and, on the other hand, bone formation does not take place above a certain high level of specific surface area because of a fast resorption. Although these findings imply that for each material there is an optimal surface area which leads to maximal osteoinduction, observations show the minimal requirement for pore size in this context to be approximately 100 μm32 because of cell transport, migration requirements and nutrient transport. Pore sizes between 300 - 400 μm are recommended because of the formation of capillaries.31, 32, 39

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172 Lambert F. et al.

Figure 5. NatixÂŽ data sheet Fig. 5: NatixÂŽ data sheet

iii. Chemical composition (pico scale;

(Ca,X)10(PO4,HPO4,CO3)6(OH,Y)2,

10-12)

where X are cations (Mg, Na or Sr ions)

The rationale for the development 15 that can substitute for the calcium ions, of calcium phosphate-based bioma-

and Y are anions (Cl or F ions) that can

terials is their similarity in composi-

substitute for the hydroxyl groups40

tion to the bone mineral and in some

[Note: calcium hydroxyapatite formula

physico-mechanical properties. The

is Ca10(PO4)6(OH)2]. Dissolution is a

natural bone mineral to which the

first and necessary step in osteogen-

ideal biomaterial claims similarity in

esis induced by biomaterials, providing

terms of chemical composition, ba-

saturation of the extracellular environ-

sically is a carbonate hydroxyapa-

ment with calcium and phosphate ions

tite rather than a calcium hydroxya-

as a prerequisite to matrix mineraliza-

patite, approximated by the formula

tion. The composition (chemical prop-

Journal of Osteology and Biomaterials

erties), but also the microstructure and topography of biomaterials strongly determine both the dissolution or resorption rate of the material, and the ability of the material to facilitate cell proliferation, cell attachment and phenotypic expression.41-45 Dissolution of biomaterials primarily depends on composition (proportions of slow-resorbing hydroxyapatite versus fast-dissolving beta-tricalcium phoshate, with higher carbonate content leading to increased substrate resorption and osteoclastogenesis)46, and for materials of similar composition, the extent of dissolution will depend on the method of preparation determining particle size, porosity (both micro and macroporosity), specific surface area, and cristallinity.41, 47-49 For instance, with respect to bovinederived apatite, dissolution showed to be the greatest for non-sintered bone without organic matrix, followed by non-sintered bone with organic matrix, and the least for sintered bone. This phenomenon can be explained on the basis of the magnitude of crystal size (much greater in sintered versus nonsintered bone when sintered above 1000° C), lower CO3 content, and the protective effect of the organic matrix phase in acidic buffered conditions.50 Recent studies have additionally shown that sintering temperatures and sintering times have great effect on density of different apatites51, 52, allowing to tailor both the mechanical properties and phase content of apatite.

For synthetic CaP, the extent of dissolution is the greatest for amorphous CaP, followed by alphatricalcium phosphate, and the least for HA48, however

Lambert F. et al.

Figure 6. GenosÂŽ data sheet Fig. 6: GenosÂŽ data sheet

strongly depending on the origin of the

it yet remains difficult to ascertain the

material and/or the preparation meth-

biological effect of carbonate substitu-

od. Results of previous studies showed

tion on osteoclasts.

that incorporation of different ions causes changes in morphological fea-

CONCLUSION

tures of crystal size and shape, as well

Although the above physicochemical

as in the dissolution properties of the 16 and morphological characteristics conapatite.49 Several reports sustain the

siderably influence the in vivo behav-

postulation that controlling carbon-

iour of the biomaterial, they are often

ate substitution in HA may be a route

not taken into consideration when the

to controlling biomaterial resorption.

materialâ&#x20AC;&#x2122;s biological performance is

However, since the resorbing cells have

evaluated, hence often producing con-

not always clearly been characterized,

flicting results found in the literature.

173

Furthermore, there are only a limited number of studies that compared the physico-chemical properties and preclinical or clinical performances of commercially available bone substitutes. As shown in this study, these synthetic materials show significant differences depending on the manufacturing process.

Some are sintered at high temperature, exhibiting low microporosity and thus having low bioactivity, whereas others are able to induce ectopic bone formation when solely implanted in muscles of animals.

Comparative studies using different biomaterials implanted in standardized animal models are of great importance to provide proof-of-principle for selecting the most appropriate bone substitute for a clinical application. Nevertheless, these types of studies are rarely found in the literature. Moreover, clinical studies comparing two or more groups of bone substitutes in standardized conditions are even more rare. In conclusion, a detailed comprehension of the influence of material characteristics on its in vivo behavior is crucial for the clinician to decide which grafting material to use for preservation or regeneration of the alveolar bone. In this context, accessibility of the physico-chemical data via a set of product data sheets may represent a helpful tool to the decision process.

Disclosure The authors declare that they have no financial relationship with any commercial firm that may pose a conflict of interest for this study.

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Original article

177

Volar plate fixation of distal radius fractures: 3 years follow-up Vincenzo Sollazzo*, Vincenzo Lorusso

Aim Distal radius fractures have been treated with caster for long time. Actually, open reduction and internal fixation with plates is the gold standard for displaced extra-articular and intra-articular distal radial fractures. Stable internal fixation permits early motion of the wrist and neighboring joints and optimizes functional rehabilitation of the wrist-hand complex.

Material and Methods Between April 2006 and April 2009 we treated 53 distal radius fractures by open reduction and internal fixation using titanium lowprofile angular stability volar plate.

After15 days we started a gradual articular mobilization. The patients underwent follow-up at 1 and 3 months from surgery and examined radiographically.

Functional outcomes were documented measuring the range of movement and the grip strength and by Gartland-Werley demerit point scoring system modified by Sarmiento, the Disability of the Arm, Shoulder and Hand (DASH) and the Patient-Rated Wrist Evaluation (PRWE) questionnaire.

Results Results show a good recovery of range of movement and grip strength without pain. Open reduction and internal fixation with low profile angular stable volar plates represent an efficient and safe procedure to treat distal radius fractures. Stable reduction permits early mobilization, an essential requirement for good functional outcomes.

(J Osteol Biomat 2011; 3:177-181)

Key words: distal radius fractures, volar fixation, internal fixation, volar plate.

Dipartimento di Scienze Biomediche e Terapie Avanzate, Sezione di Clinica Ortopedica, Università di Ferrara, Ferrara.

Corresponding author: * Vincenzo Sollazzo MD Orthopedic Clinic - University of Ferrara Corso Giovecca 203 - 44120 Ferrara, Italy Phone: +39532236573 - Fax: +39532209250 Email: slv@unife.it

INTRODUCTION Seventeen percent of all fractures observed in the emergency room1 are distal radius fractures, representing the most frequent bone trauma of the upper limb. Fourteen percent of all extremities injuries are wrist fractures and distal radius fractures, 75% of forearm fractures are with or whitout a compromised ulna2.

In elderly people, proximal femur fractures prevail in women3. Distal radius fracture generally depend on a fall on the wrist in dorsal flexion. Their morphology depends on load factors such as size, direction and rate and on areas where the forces act. When these fractures involve young people, they are high energy trauma.

Pattern fracture depends on angle and impact strength. Very comminute fractures follow a wide load angle (from 70° to 90°), minimally comminute fractures a smaller load angle (from 20° to 40°). When dorsal flexion goes over 90°, carpal damage is associated.

Although distal radius is the most common fracture site of the human skeleton, the treatment of these fractures can still be troublesome because not universally standardized. In spite of the literature data that highlight the need for anatomical reduction of the articular surface and extra-articular

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Sollazzo V. and Lorusso V.

Figure 1 (A,B,C) The Aculoc plate (Acumed) shows an antomic design studied on the volar surface of the distal radius.

alignment5, these fractures are often inapropriately treated with caster, resulting in degenerative changes and in radio-carpal and distal radio-ulnar incongruity6.

The residual deformities after distal radius fractures results in a functional decrease of the wrist and hand, pain at movement, range of movement restriction, grip strength reduction, ulnar-carpal conflict, early osteoarthritis of radio-carpal and distal radio-ulnar bone14.

Over the past years, the treatment approach to fractures of the distal radius has undergone an important evolution. Open reduction and internal fixation followed by early motion, the gold standard for periarticular fracture care,

has replaced conservative treatment with plaster and greatly improved treatment outcome.

Starting from this point, over the past years the treatment of these fractures have undergone an important evolution aiming to obtain a functional recovery by anatomical reduction and stable fixation7. It is well-know that early motion is the gold standard in periarticular fractures8, so the actual implants must be able to assure the stability of distal radius with subchondral support and allow the early articular motion.

The production of anatomical titanium plates, strong and thin was the presupposition of the modern internal fixation of distal radius fractures9.

Table 1. Types of fractures following Melone-Geissler classification

Fractures type IIa with dorsal dislocation of fragments

9

Fractures type IIb with volar dislocation of fragments

21

Fractures type III with displacement of a digital volar spike fragment from the comminuted radial shaft Fractures type IV presenting a wide separation or rotation of the volar and dorsal ulnar fragments Fractures type V with extensive comminution both of the articular surface and metaphysis

Journal of Osteology and Biomaterials

2 9 4

MATERIALS AND METHODS Between April 2006 and April 2009 we treated 53 distal radius fractures by open reduction and internal fixation using titanium low-profile angular stability volar plate (Figure 1 and Figure 2). There were 52 patients (1 bilateral fractures), 13 men and 39 women with a mean age of 57.76 years (23-84) and the dominant wrist was fractured in 22. We lost seven of these patients to follow-up. According to the classification of Melone modified Geissler (Table 1), we treated 9 fractures with dorsal dislocation and compression of dorsal ulnar fragment (IIa), 21 fractures in which distal fragments were dislocated anteriorly (IIb), 2 fractures with displacement of the medial complex as a unit, as well as displacement of a digital volar spike fragment from the comminuted radial shaft (III), 9 fractures with the medial complex severely compressed by the lunate resulting in a wide separation or rotation of the volar and dorsal ulnar fragments (IV) and 4 fractures with extensive comminution, both of the articular surface and metaphysis (V).

The internal fixation was performed with a Henry volar approach by lon-

Sollazzo V. and Lorusso V.

179

54.96). The PRWE pain score was 4/50 (0-13), the function score was 7/50 (015), the total mean score was 8.14/100 (0-21).

Figure 2 (A,B) The Aculoc plate permits the use of screws an pegs with angular stability.

Two holes of the plate are dedicated for radial styloid fixation.

gitudinal incision along the radial flexor carpi. We used the Aculoc plate (Acumed), a titanium low profile angular stability volar plate.

The patient underwent surgical treatment, performed by the same surgeon, he was immobilized in a brachial-metacarpal plaster cast for two weeks. After 15 days the suture was removed and a gradual articular mobilization was started.

The patient was followed-up at 1 and 3 months from the surgery and examined by standard postero-anterior and lateral radiographs of the fractured wrist.

The functional outcomes measured were the range of movement (ROM) by a goniometer and grip strength (JAMAR Hand Dynamomer, CAMP Ltd, Northgate House, Winchester, Hants) related percentage-wise to the other hand. Further wrist scores according to Gartland-Werley demerit point scoring system modified Sarmiento, the Disability of the Arm, Shoulder and Hand (DASH) and the Patient-Rated Wrist Evaluation (PRWE) questionnaire were used10,11,12.

The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their lev-

els of wrist pain and disability from 0 to 10, and consists of 2 subscales, pain and function.

RESULTS All distal radius fractures healed. There where no intraoperative complications, no wound complications and no infections.

At 3 months from surgery, pain was absent in 9 patients (20%) and moderate and occasional, generally under stress, in 36 (80%). We didn’t observe nerve complications, poor finger function or residual deformity except radial deviation on the hand in 5 patients with slight limitation of motion.

Wrist flexion averaged 79° (range, 4585°) and wrist extension averaged 65° (range 0-74°). The mean pronation was 70° (60°-75°), the mean supination 75° (70°-80°). The mean ulnar and radial deviation were, respectively, 24° (20-25°) and 17.5° (15-20°). Ipsilateral grip strength averaged 66.7% (26.65% 105.5%) of that measured on the unaffected extremity).

According to Gartland-Werley demerit point scoring system, the results were good in 14 patients (31%) and excellent in 31 patients (69%.

The mean DASH score was 24.64 (0-

DISCUSSION The old concepts according to wrist to be suitable to post traumatic deformities are definitively overcame by the acquisition that only the anatomical reduction can assure the full recovery of articular function.

The residual deformities after distal radius fractures result in a functional decrease of wrist and hand, pain on movement, range of movement restriction, grip strength reduction, ulnar-carpi conflict, early osteoarthritis of distal radial-carpal and radio-ulner.13,14 Over the past years, the treatment approach to fractures of the distal radius has undergone an important evolution. Open reduction and internal fixation followed by early motion, the gold standard for periarticular fracture care, has replaced conservative treatment with plaster and greatly improved treatment outcomes.

The traditional surgical rationale, dorsal approach in dorsally displaced fractures, volar approach in volarly displaced fractures has been partially abandoned because of disappointing results. The dorsal approach requires extensive dissection of the extensor tendon sheaths, resulting in scar formation and limitation of movement.7 Dorsal plates are in direct contact with extensor tendons, often resulting in tenosynovitis and tendon ruptures.15 In addition, in fractures with extensive comminution the reduction is more difficult and the small comminuted cortical fragment devascularization hinders

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Sollazzo V. and Lorusso V.

the healing process.16 The volar approach, on the contrary, presents many advantages. The concave shape of the volar distal radius is a natural lodging for the plate and the flexor tendons do not come in contact with the plate thanks to the pronator quadratus interposition. A volar approach, finally, allows to manage both dorsal and volar displaced fractures.17 We used in all patients the same titanium-low-profile plate. The distal screws, angled forward six degrees from the plate, maximize engagement in the subchondral bone.

The fixed angle support was advantageous when working with osteoporotic bone. The use of volar plates for the treatment of distal radius fractures has shown good or excellent clinical results and low complication rates.

There were no infection or wound healing problems and no nerve complication. Our patients, thanks to the stable reduction and the early motion, obtained a very good range of motion on all the planes. Grip strength recovery seemed quite functional as the grip strength was 66.7% of the opposite side. The best result was in one patient with the dominant side affected that developed a grip strength of 105.5%; the worst result was 26.65% in a patient with the non-dominant side affected. Our results suggest that the open reduction and internal fixation with low profile angular stability volar plates represent an efficient and safe procedure to treat both dorsal and volar displaced distal radius fractures.

The surgical technique is simple and can be used also in the more complex fractures. The functional outcomes are good or excellent with a low complication rate.

Journal of Osteology and Biomaterials

Acknowledgments The authors declare that they have no financial relationship with any commercial firm that may pose a conflict of interest for this study.

Sollazzo V. and Lorusso V.

REFERENCES 1. Simic PM, Weiland AJ. Fractures of the distal aspect of the radius: changes in treatment over the past two decades. Instr Course Lect 2003;52:185-195.

2. Alffram PA, Bauer GCH. Epidemiology of fractures of the forearm: a biomechanical investigation of bone strength. J Bone Joint Surg 1962;44A:15-114.

3. Owen Ra, Melto JL III, Johnson KA et al. Incidence of Colles’ fracture in a North American community. Am J Pub Health 1982;72:605-607.

4. Weber ER. A Rational approach for the recognition and treatment of Colles’ fracture. Hand Clin 1987;3:3-21.

5. Short WH, Palmer AK, Werner FW et al. A biomechal study of distal radial fractures. J Hand Surg 1987;2°:529-34.

181

measurements in evaluating recovery after a distal radius fracture. J Hand Surg 2000;25:330-40.

13. Pogue DG, Viegas S. Effects of distal radio fracture malunion on wrist joints mechanics. J Hand Surg Am 1990;15:721-727.

14. Geissler WB, Freeland A. Intracarpal soft-tissues lesions associated with intra-articular fractures of the distal end of the radius. J Bone Joint Surg Am 196;78:357-365.

15. Kambouroglou G,Axelrod T. Complications of the AO/ASIF titanium distal radius plate system. J Hand Surg Am 1998;23:737741.

16. Henry MH, Griggs SM, Levaro F, et al.

Volar approach to dorsal displaced fractures of the distal radius. Tech Hand Upper Extrem Surg. 2001;5:31-41.

6. Van der Linden W, Ericson R. Colles’ fracture: how should its displacement be measured and how shold it be immobilized? J Bone Joint Surg 198; 63A:1285-91.

7. Fernandez DL. Should anatomic reduction be pursued in distal radial fractures? J Hand Surg 2000:25B:523-7.

8. Rikli D, Regazzoni P. Fractures of the distal end of the radius treated by internal fixation and early function. J Bone Joint Surg Br 1996;78:588-592.

9. Carter P, Frederick H. Open reduction and internal fixation of unstable distal radius fractures with a low-profile plate. J Hand Surg Am 1998;232:300-307.

10. Nelson FS, McDonald AP, Seiller JG. Evaluetion of the Construct Validity of the DASH questionnaire by Correlation to the SF-36. J Hand Surg 2002;27A:537-41.

11. American Accademy of Orthopaedic Surgeons. Scring Algorithms for the Disabilities of the Arm, Shoulder and Hand outcomes data collection instrument, version2.0. 1997 Resemont, I7.

12. MacDermid JC, Richards RS, Donner A, Bellamy N,Roth JH. Responsiveness of the short form-36, disability of the arm, shoulder, and hand questionnaire, patient-rated wrist evaluation, and physical impairment

Volume 2 - Number 3 - 2011

BioCRA

Case report

183

Implant-retained prosthesis in a patient affected by von Recklinghausen’s Neurofibromatosis 1: a case report.

Saverio Capodiferro DDS1*, Nunzio Francesco Testa MD1, Carlo Lajolo DDS2, Eugenio Maiorano MD, MS3, Gianfranco Favia MD, DMD1

Neurofibromatosis type 1 also known as von Recklinghausen’s neurofibromatosis, is an autosomal dominant inherited genetic disorder, quite frequently involving the head and neck region with intra-oral neurofibromas (involving the tongue, the gingiva, the palate, the cheeks, the lips, the floor of the mouth), abnormalities of mandible and inferior alveolar nerve, tooth loss, impaction and malpositioning of the teeth. We report a case of a middle-age woman affected by neurofibromatosis type 1 who received a prosthetic rehabilitation by endosseous implants, which led to a functional, aesthetic and also psycho-social rehabilitation of the patient.

(J Osteol Biomat 2011; 3:183-187)

Key words: neurofibromatosis, endosseus implant, teeth-implants rehabilitation

1 2 3

Department of Dentistry and Surgery - University of Bari, Bari – Italy Department of Dental Sciences- University LaSapienza, Rome – Italy Department of Pathological Anatomy- University of Bari, Bari – Italy

Corresponding author: *Dr. Saverio Capodiferro Department of Odontostomatology and Surgery University of Bari - piazza Giulio Cesare, 11 70124 Bari-Italy tel.: +39 (080) 5478155 fax.: +39 (080) 3430453 e-mail:saveriocapodiferro@libero.it

INTRODUCTION Neurofibromatosis type 1 (NF1), also known as von Recklinghausen’s neurofibromatosis, is an autosomal dominant inherited genetic disorder, associated with deletions, insertions or mutations of the NF1 gene located in the pericentromeric region of chromosome 17, affecting 1:3000 newborns without prevalence for gender or race but with a highly variable phenotypic expression(1,2). NF1 has almost 100% penetration, but variable expression. In addition, 50% of cases are sporadic and arise from germ-cell mutations .1 NF1 is characterized by cafe’ au lait spots, intertriginous freckling, Lisch nodules and multiple cutaneous neurofibromas.2 Besides, NF1 can be associated with optic gliomas, spinal and peripheral nerve neurofibromas, neurologic or cognitive impairment, scoliosis and abnormalities in the oral and maxillofacial region (abnormalities of mandible and inferior alveolar nerve, etc..), malignant tumours of the nerve sheath, pheochromocytoma, and vasculopathy 2,3,4,5. Neurofibromas are the hallmark of the NF1 and usually appear during childhood or adolescence after the emergence of cafe´ au lait spots.

They form tumours on the tongue, the gingiva, the palate, the cheeks, the lips, the floor of the mouth or the pharynx.

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184 Capodiferro S. et al.

Figure 1. The patient was affected by a moderate-serious periodontitis with numerous decayed teeth. A panoramic radiograph and dental scan showed morphological alterations both of the mandible and of position and form of the inferior alveolar nerve; signs of previous bone grafts on both sides of the mandible were evident about which no further information were available (a, b, c); d. cafeâ&#x20AC;&#x2122; au lait spots and multiple cutaneous neurofibromas were observable widespread on the skin..

Besides tooth loss, impaction and malpositioning of the teeth are frequently found 4.

CASE PRESENTATION The patient is a middle-age woman (49 year-old) affected by NF1 who, more than 20 years ago, underwent surgical procedures (no further information is available) for ridge augmentation in the mandible due to abnormalities of the mandible and mal-position of the inferior alveolar nerve. Three years ago, after a long period of oral/dental neglect, she decided to rehabilitate her teeth requesting a fixed prosthesis (Figure 1). The periodontal status was dramatic and for such reason extraction of all compromised teeth was performed

Journal of Osteology and Biomaterials

and after an appropriate healing time (approximately 3 months) a rehabilitation with fixed metal-ceramic prosthesis retained by Osseotite implants (Biomax 3i) was planned for both jaws, considering the morphological alterations of the mandible and of the position of the inferior alveolar nerve, which are typical of the NF1.

In the maxilla, the four incisor were replaced immediately after extraction by four implants similar to all the missing teeth; for the replacement of the second right premolar and the first molar, a trans-alveolar sinus floor elevation performed by osteotomes was necessary, together with a vertical augmentation of the alveolar bone, performed with bovine bone and re-absorbable

membrane; the patient refused more invasive surgical procedures (Figure 2).

In the mandible, four implants were placed to extend rehabilitation at least to the first molar. Unfortunately, in the 4.5 site, two implant failures occurred and the patient refused another intervention; however, a fixed restoration was obtained in the maxilla and also in the mandible (which was completed with a teeth-implant rehabilitation in the right side). (Figure 3)

Capodiferro S. et al.

DISCUSSION NF is an extremely variable disorder.

The severity of NF ranges from extremely mild cases in which the only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal neurofibromas, to more severe cases in which one or more serious complications may develop(1).

NF1 is present in individuals with two of the following criteria, provided that no other disease accounts for the findings.

1. Family history of NF1 2. 6 or more light brown (“cafe-aulait”) spots on the skin 3. Presence of pea-sized bumps (neurofibromas) on the skin 4. Larger areas on the skin that look swollen (plexiform neurofibromas) 5. Freckling under the arms or in the groin area 6. Pigmented bumps on the eye’s iris (Lisch nodules) 7. Skeletal abnormalities such as tibial dysplasia (bowing of the legs), or thinning of the shin bone 8. Tumour on the optic nerve that may interfere with vision.

185

Figure 2. The four upper incisors were replaced by four implants positioned immediately after extraction to preserve soft and hard tissues in aesthetic zone; all other missing teeth were replaced by implants in the maxilla; in the posterior right maxilla, a trans-alveolar sinus elevation was necessary to place two implants together with a vertical ridge augmentation with bovine bone and re-absorbable membrane (a). In the mandible, four implants were necessary to extend rehabilitation to the first molar; unfortunately, two failures occurred in the 4.5 area and the patient refused any surgical treatment. For such reason, a prosthesis supported by tooth-implant was positioned in this area; the post-operative panoramic radiograph showed the good osseointegration of implants and the final restoration only of the maxilla at that time (b).

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186 Capodiferro S. et al.

CONCLUSIONS The treatment of patients affected by systemic disorders with oral-facial involvement, as in the reported case, is surely difficult, firstly because of the dento-maxillo-facial abnormalities and secondly because these particular patients are psychologically adverse to the necessity of surgical procedure, althought necessary. In fact, the functional and aesthetic rehabilitation obtainable thanks to implantology, also in extremely difficult cases, should first be aimed at the â&#x20AC;&#x153;psycho-social rehabilitationâ&#x20AC;? of these particular patients6.

Figure 3. The final appearance of prosthetic restoration (a,b,c); on the face of the patient where evident signs of previous surgical procedures are present and also numerous neurofibromas on the neck, the face and skin.

Journal of Osteology and Biomaterials

Capodiferro S. et al.

187

REFERENCES 1. Friedman JM, Birch PH. Type 1 neurofibromatosis: a descriptive analysis of the disorder in 1,728 patients. Am J Med Genet 1997;70:138–143.

2. Friedman JM, Riccardi VM. Clinical and epidemiological features. In: Friedman JM, Gutmann DH, MacCollin M, Riccardi VM, eds. Neurofibromatosis: phenotype, natural history, and pathogenesis. Johns Hopkins University Press. 1999. Baltimore, MD, pp. 29–86.

3. Friedrich RE, Giese M, Schmelzle R et al.

Jaw malformations plus displacement and numerical aberrations of teeth in neurofibromatosis type 1: a descriptive analysis of 48 patients based on panoramic radiographs and oral findings. J Craniomaxillofac Surg 2003;31:1–9.

4. Shapiro SD, Abramovich K, van Dis ML, et al. Neurofibromatosis: oral radiographic manifestations. Oral Surg 1984;58:493– 498.

5. D’Ambrosio JA, Langlais RP, Young RS. Jaw and skull changes in neurofibromatosis.

Oral Surg 1988;66:391–396.

6. Muller F, Schadler M, Wahlmann U, Newton JP. The use of implant-supported prostheses in the functional and psychosocial rehabilitation of tumor patients. Int J Prosthodont 2004;17:512-7

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