Instradent Regenerative Solutions by Straumann Group

INSTRADENT速 Regenerative solutions

Access to reliability and predictability

02 | Instradent hard tissue

INSTRADENT® XENOGRAFT Reliable bone volume1–9

Similar to human bone, the Instradent® XenoGraft is a Deproteinized B ovine Bone Mineral (DBBM) with low cristallinity, high porosity and an optimal balance of calcium and phosphate designed to a chievereliable bone volume in guided bone regeneration ultimately achieving esthetic results.

EXCELLENT BIOCOMPATIBILITY

OPTIMAL BONE REGENERATION

§§Optimal balance of calcium and phosphatecomparable to human bone. §§Apatite structure deproteinized, delipidized, and sterilized via gamma irradiation.

§§Low crystallinity providing a favorable surface to which new bone can adhere. §§High porosity supporting the osteo- conduction for having a structural scaffold for vascular ingrowth and bone formation.

PREDICTABLE BONE VOLUME

FLEXIBLE PROCEDURE

§§Consistent particle size creating a predictable scaffold with a favorable tactile feel when drilling. §§Slow resorption rate helping to achieve long term volume.

§§Can be mixed with either autogenous or allograft bone. §§Combine with the Instradent Membrane to maintain ideal space and long-term cell occlusion for maximizing bone volume.

Processing assures biocompatibility Instradent® XenoGraft is methodically processed from bovine bone and extensively tested to eliminate antigenicity and provide a favorable environment for new bone growth. Indeed, the granules have been treated at 600°C to achieve a low crystallinity, high content of carbonate ions, and porous structure which showed a better osteoconductivity comparing to granules treated with a higher temperature.3

Step 1: Bovine bone ground to particulate

Step 2: Lipids and proteins removed through vigorous washes and high-temperature

Step 3: Low crystallinity achieved at 600° to create a favorable surface to which bone can adhere

Step 4: Terminal sterilization via gamma irradiation

Instradent hard tissue | 03

SCIENCE The Instradent® XenoGraft is comparable to the standard DBBM with a low cristalinityand similar particles size and porosity. Additionally, the Instradent® XenoGraft provides a comparable Ca/P ratio to the human bone for an optimal biocompatibility and has consistent particle size for having the reliable framework for new bone growth and for achieving bone volume.

Competitor DBBM

Instradent XenoGraft

Mole ratio of Ca/P14 Nanocrystalline surface structure 1,70

1,68

Small granules (0.2 – 1.0mm) 1,60

1,59

1,50

Large granules (1.0 – 2.0mm)

Human bone

Competitor DBBM

Instradent XenoGraft

Particle size distribution14 100

96% 63,6%

30,5% 5,6%

0,8 – 1,0mm × 20

× 20

0,4 – 0,8mm

0,2 – 0,4mm

Competitor DBBM

0,3%

0,1 – 0,2mm

Instradent XenoGraft

The Instradent® XenoGraft shows in clinical trial or in a preclinical study its successful outcomes in Guided Bone Regeneration (GBR) improving key clinical parameters.

Histomorphometric analysis, preclinical study14 2 weeks

4 weeks

8 weeks

A radiographical study on the changes in height of grafting materials after sinus lift9 25

11,52

New bone (%) 7,66

9,25

4,48 5,73 0

3,09 -25

Graft (%)

70,10

67,89

65,02

68,37

65,25

63,21

-50

Competitor DBBM

Instradent XenoGraft

Competitor DBBM

Instradent XenoGraft

The clinical study showed that over time there was no statistically significant difference between the two bone grafting materials. The two bone grafting materials show comparable resorption results with no statistically significant differences when used in sinus lift procedures.9

04 | Instradent soft tissue

INSTRADENT® MEMBRANE Predictable regeneration10–14

Instradent® Collagen Membrane (type I) is a porous non-chemical cross- linkingporcine-derived (dermis) fibrous membrane designed to achieve predictable guided bone r egeneration and tissue regeneration.

OPTIMAL BARRIER FUNCTION

FLEXIBLE PROCEDURE

§§Cross-linked collagen without chemicals allowing a slow and predictable barrier resorption rate from 4 to 6 months providing ideal condition for bone growth. §§Fibrous structure enabling cell occlusion supporting bone regeneration, protecting the graft area of unwanted soft tissue infiltrations during the initial healing phase.

§§Can be placed in conjunction with any bone grafting material or as a standalone solution. §§Available in 3 different sizes.

STABILITY FOR OPTIMAL BONE HEALING

EASY-TO-HANDLE AND QUICK APPLICATION

§§High tear resistance allowing a wide variety of fixing methods, including pins and sutures enhancing undisturbed bone regeneration site. §§Multi-layers structured of type 1 collagen providing bone healing stability and soft tissue support.

§§Either side can be placed dry or hydrated, so not side specific. §§Easily repositionable for precise placement.

Processing assures biocompatibility Instradent® Collagen Membrane is meticulously manufactured from highly purified native collagen, ideal choice for the excellent biocompatibility and capacity to enhance wound healing process. The cross-linking has been achieved without chemicals (such as formaldehyde and glutaraldehyde) to avoid any adversely influences on surrounding tissues or leave of cytotoxic residue during the process.12, 13

Step 1: Processed collagen from porcine dermis

Step 2: Washing to remove processing residues

Step 3: Interlaced for crosslinking increases mechanical strength

Step 4: Washing to remove residues crosslinked

Step 5: Drying and packaging

Step 6: End gamma radiation sterilization

Instradent soft tissue | 05

SCIENCE The Instradent® Collagen Membrane has a multi-layer fibrous structure designed for acting as a cell occlusive barrier which protects the healing site. The porous surface is designed to helps vascularization enhancing the soft and hard tissue healing. Additionally, its high tear resistance preserves undisturbed the bone regeneration site.

Competitor: Bilayer collagen membrane

Instradent collagen membrane

Surface view | × 1.50k

Cross-sectional view | × 500

Tensile strength 14 (in N/mm ) 2

16,6

16,1 14,8

4,7

4,4

4,7

Run 1

Run 2

Run 3

Competitor: Bilayer collagen membrane

Instradent collagen membrane

The Instradent® Collagen Membrane shows in a randomized clinical trial or in a preclinicalstudy its successful outcomes in Guided Tissue Regeneration (GTR) or in Guided Bone Regeneration (GBR) improving key clinical parameters. New bone formation in a preclinical study14 (in %)

Randomized clinical trial in periodontal intrabony defects, 3 months results 11 (in mm)

4 weeks

8 weeks

16 weeks 64,3

-3,6

Plaque index change

56,2

-5,1

44,8

Clinical attachement level gain

2,5 3,6

61,6 53,2

41,3 20

5,0

Bone Fill 5,8 0

Competitor: Bilayer collagen membrane

Instradent collagen membrane

Competitor: Bilayer collagen membrane

Instradent collagen membrane

06 | Instradent products

PRODUCT AVAILABILITY

Instradent® XenoGraft

Granule size 0.2 mm 1.0 mm 2.0 mm

Package volume 0.25 g, 0.50 g, 1.0 g, 2.0 g 0.25 g, 0.50 g, 1.0 g, 2.0 g 0.25 g, 0.50 g, 1.0 g, 2.0 g

Storage 15°C – 25°C, dry place Shelf life 3 years

References : 1. A study on the safety and efficacy of bovine bone-derived bone graft material (OCS-B). J Korean Acad Periodontol. 2005 Jun;35(2):335-343. 2. Evaluation on the bone regenerative capacity of deproteinized bovine bone-derived bone graft material (OCS-B). The Journal of the Korean Dental Association. Vol.44 No.6, 2006.6, 359-366. 3. Effect of Heat-Treatment Temperature on the Osteoconductivity of the Apatite Derived from Bovine Bone, Key Engineering Materials Vols. 309-311 (2006) pp 41-44 4. Bone reaction to bovine hydroxyapatite grafted in the mandibular defects of beagle dogs. J Korean Acad Periodontol. 2006;36:39-49. 5. Maxillary sinus floor augmentation using deproteinized bovine bone-derived bone graft material (OCB-B®). Clinical and histologic findings in human. The Journal of the Korean Dental Association. 2007; 45(8): 491-499. 6. Periodontal Repair on Intrabony Defects treated with Anorganic Bovine-derived XenoGraft. J Korean Acad Periodontol. 2007; 37(3): 489-496. 7. The comparative study - the regenerative effect depends on size of bone graft material in bone loss site around dental implant. J Korean Acad Periodontol. 2008;38:493-502. 8. A comparative analysis of basic characteristics

Instradent products | 07

Instradent® Membrane

Thickness / surface Size 280 ± 90 microns / smooth 30 × 25 mm 280 ± 90 microns / smooth 25 × 15 mm 280 ± 90 microns / smooth 20 × 10 mm Storage controlled temperature below 23°C, dry place Shelf life 3 years

of several deproteinized bovine bone substitutes. J Korean Acad Periodontol. 2009;39:149-156. 9. A radiographical study on the changes in height of grafting materials after sinus lift: a comparison between two types of xenogenic materials, J Periodontal Implant Sci 2010;40:25-32 10. Comparative study of two collagen membranes for guided tissue regeneration therapy in periodontal intrabony defects: a randomized clinical trial; Young-Mi Chung, Jue-Yeon Lee, Seong-Nyum Jeong; J Periodontal Implant Sci 2014; 44:194-200 11. Biological effects of a porcine-derived collagen membrane on intrabony defects; Chang-Kyun Lee, Ki-Tae Koo, Tae-Il Kim, Yang-Jo Seol, Yong-Moo Lee, In-Chul Rhyu, Young Ku, Chong-Pyoung Chung1, Yoon-Jeong Park, Jue-Yeon Lee; J Periodontal Implant Sci 2010;40:232-238 12. Speer DP, Chvapil M, Eskelson CD, Ulreich J. Biological effects of residual glutaraldehyde in glutaraldehyde-tanned collagen biomaterials. J Biomed Mater Res 1980;14:753-64. 13. Locci P, Calvitti M, Belcastro S, Pugliese M, Guerra M, Marinucci L, et al. Phenotype expression of gingival fibroblasts cultured on membranes used in guided tissue regeneration.J Periodontol 1997;68:857-63. 14. Data on files

INTERNATIONAL HEADQUARTERS INSTRADENT Peter Merian-Weg 12 Phone: +41 (0)61 965 11 11 CH-4002 Basel, Switzerland Fax: +41 (0)61 965 11 01

E-mail: info@instradent.com Web: www.instradent.com