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Instradent Regenerative Solutions

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Access to reliability and predictability INSTRADENT® Regenerative solutions
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Page 1: Instradent Regenerative Solutions

Access to reliability

and predictability

INSTRADENT® Regenerative solutions

Page 2: Instradent Regenerative Solutions

INSTRADENT® XENOGRAFT

Reliable bone volume1–9

Similar to human bone, the Instradent® XenoGraft is a Deproteinized Bo vine

Bone Mineral (DBBM) with low cristallinity, high porosity and an optimal

balance of calcium and phosphate designed to achieve reliable bone volume

in guided bone regeneration ultimately achieving esthetic results.

02 | Instradent hard tissue

EXCELLENT BIOCOMPATIBILITY

§Optimal balance of calcium and

phosphate comparable to human bone.

§ Apatite structure deproteinized,

delipidized, and sterilized via gamma

irradiation.

FLEXIBLE PROCEDURE

§ 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.

PREDICTABLE BONE VOLUME

§ Consistent particle size creating a predic-

table scaffold with a favorable tactile feel

when drilling.

§ Slow resorption rate helping to achieve

long term volume.

OPTIMAL BONE REGENERATION

§ 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.

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

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 osteo conductivity comparing to granules

treated with a higher temperature.3

Page 3: Instradent Regenerative Solutions

0

70,10 67,8965,02

68,3765,25

63,21

The Instradent® XenoGraft is comparable to the standard DBBM with a low cristalinity and

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.

Instradent hard tissue | 03

The clinical study showed that over time there was no statistically sig-

nificant 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

The Instradent® XenoGraft shows in clinical trial or in a preclinical study its successful outcomes

in Guided Bone Regeneration (GBR) improving key clinical parameters.

0

4,48

7,66

11,52

3,09

9,25

5,73

New bone (%)

Graft (%)

Competitor DBBM Instradent XenoGraft

25

-50

-25

0

Competitor DBBM Instradent XenoGraft

A radiographical study on the changes in height of grafting

materials after sinus lift9

Histomorphometric analysis, preclinical study14

2 weeks 4 weeks 8 weeks

Mole ratio of Ca/P14

1,50

1,60

1,70

1,68 1,68

1,59

Human bone Competitor DBBM Instradent XenoGraft

Competitor DBBM Instradent XenoGraft

Competitor DBBM Instradent XenoGraft

× 20× 20

100

50

0

0,8 – 1,0mm 0,4 – 0,8mm 0,2 – 0,4mm 0,1 – 0,2mm

5,6%2%

63,6%

96%

30,5%

1% 0,3%

Competitor DBBM Instradent XenoGraft

Particle size distribution14

SCIENCE

Nanocrystalline surface structure

Small granules (0.2 – 1.0mm)

Large granules (1.0 – 2.0mm)

Page 4: Instradent Regenerative Solutions

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 formal-

dehyde and glutaraldehyde) to avoid any adversely influences on surrounding tissues or

leave of cytotoxic residue during the process.12, 13

Step 5:

Drying and

packaging

Step 6:

End gamma

radiation

sterilization

Step 1:

Processed

collagen

from porci-

ne dermis

Step 2:

Washing

to remove

processing

residues

Step 3:

Interlaced for

crosslinking

increases

mechanical

strength

Step 4:

Washing

to remove

residues

crosslinked

INSTRADENT® MEMBRANE

Predictable regeneration10–14

04 | Instradent soft tissue

EASY-TO-HANDLE AND QUICK

APPLICATION

§ Either side can be placed dry or hydrated,

so not side specific.

§ Easily repositionable for precise

placement.

OPTIMAL BARRIER FUNCTION

§ Cross-linked collagen without chemicals

allowing a slow and predictable barrier

resorption rate from 4 to 6 months provi-

ding ideal condition for bone growth.

§ Fibrous structure enabling cell occlusion

supporting bone regeneration, pro-

tecting the graft area of unwanted

soft tissue infiltrations during the

initial healing phase.

FLEXIBLE PROCEDURE

§ 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

§ 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.

Instradent® Collagen Membrane (type I) is a porous non-chemical cross-

linking porcine- derived (dermis) fibrous membrane designed to achieve

predictable guided bone regeneration and tissue regeneration.

Page 5: Instradent Regenerative Solutions

44,8

56,2

64,3

53,2

61,6

0

60

4 weeks 8 weeks 16 weeks

20

40

41,3

The Instradent® Collagen Membrane shows in a randomized clinical trial or in a preclinical study

its successful outcomes in Guided Tissue Regeneration (GTR) or in Guided Bone Regeneration

(GBR) improving key clinical parameters.

SCIENCE

Instradent soft tissue | 05

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.

-3,6

-5,1

2,5

3,6

5,0

5,8

Plaque index change

Clinical attachement

level gain

Bone Fill

Competitor: Bilayer collagen membrane Instradent collagen membrane Competitor: Bilayer collagen membrane Instradent collagen membrane

Run 1 Run 2 Run 3

4,4

0

10

20

16,1

4,7

14,8

4,7

16,6

Competitor: Bilayer collagen membrane Instradent collagen membrane

Tensile strength 14

(in N/mm2)

New bone formation in a preclinical study14

(in %)

Surface view | × 1.50k

Competitor: Bilayer collagen membrane Instradent collagen membrane

Cross-sectional view | × 500

Randomized clinical trial in periodontal intrabony

defects, 3 months results 11

(in mm)

Page 6: Instradent Regenerative Solutions

Instradent® XenoGraft

Granule size Package volume

0.2 mm 0.25 g, 0.50 g, 1.0 g, 2.0 g

1.0 mm 0.25 g, 0.50 g, 1.0 g, 2.0 g

2.0 mm 0.25 g, 0.50 g, 1.0 g, 2.0 g

Storage

15°C – 25°C, dry place

Shelf life

3 years

PRODUCT AVAILABILITY

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 mate-

rial (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

06 | Instradent products

Page 7: Instradent Regenerative Solutions

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 gingi-

val fibroblasts cultured on membranes used in guided tissue regeneration.J Periodontol 1997;68:857-63. 14. Data on files

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

Instradent® Membrane

Instradent products | 07

Page 8: Instradent Regenerative Solutions

INTERNATIONAL HEADQUARTERS

INSTRADENT

Peter Merian-Weg 12

CH-4002 Basel, Switzerland

Phone: +41 (0)61 965 11 11

Fax: +41 (0)61 965 11 01

E-mail: [email protected]

Web: www.instradent.com


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