vitality meets bone volume around dental implants Straumann BoneCeramic

Straumann

_BoneCeramic

vitality meets bone volume

1

patient’s own bone regeneration is a key factor to success­ ful osseointegration of the dental implants.

straumann® _{BoneCeramic gradually resorbs and becomes} substituted by new vital bone.

Bone volume restoration and preservation are essential requirements in order to achieve esthetic results successfully. straumann® _{BoneCeramic is engineered to support resto­} ration and preservation of bone volume.

the vitality you need

around your implants

Bone volume restoration and

preservation for the desired

esthetic outcome

2

NMT NMB

SBC Image by PD Dr. F. Schwarz. Methyl Green staining, original magnification X 400

bone formation accompanies

straumann

_{BoneCeramic degradation}

Bone formation accompanies Straumann® _{BoneCeramic degradation in vivo}1,2

NMB: new mineralized bone

NMT: non mineralized tissue displaying osteogenetic activity SBC: straumann® _{BoneCeramic particle}

Arrows: straumann® _{BoneCeramic degradation (grey zones)}

images and data from a preclinical canine study by pd dr. f. schwarz. data on file2_.

3 SBC

SBC

BV NFB

Collagen type i formation Bone synthesis Blood vessel formation

Osteoid

Osteoblasts

Blood vessels

Image by PD Dr. F. Schwarz. Collagen type I staining, original magnification X 400

Image by PD Dr. F. Schwarz. Osteocalcin staining, original magnification X 400

Image by PD Dr. F. Schwarz. Transglutaminase II staining, original magnification X 400

Collagen i fibres (arrow), major component of the bone matrix, clearly indicate osteogenesis.

bone formation accompanies

straumann

_{BoneCeramic degradation}

osteoblasts (arrow), cells responsible for bone synthesis, present in the new forming bone (nfB). Blood vessels (Bv) grow through straumann® BoneCeramic augmented bone supplying nutrients for bone genera­ tion.

Sustained bone formation over healing time

antigenic reactivity indicating bone formation over time

0 10 20 30 40 50 1 week

Mean antigenic reactivity (%)

4

NMB SBC

designed to restore patient's own bone

straumann

_BoneCeramic

significantly less residual bone p

substitute and more non mineralized tissue (including bone marrow and connective tissue) with straumann® BoneCeramic, compared to bovine bone mineral, 6–7 months post augmentation, in sinus floor eleva­ tion3

equivalent new mineralized bone, p

in comparison to bovine bone mineral3

28.35 % average newly formed p

mineralized bone with straumann® BoneCeramic versus 22.27 % with bovine bone mineral, between 6 and 8 months post augmentation (p = 0.6024)4

trend of increase in mineral bone p

formation over healing time with straumann® _BoneCeramic4 Bone vitality was a 100 % in all p

cores harvested4

significant increase in mineral p

bone area over healing time with straumann® _{BoneCeramic in a} composite with autogenous bone, in sinus floor elevation5

residual graft non mineralized tissue mineralized bone

NMB: new mineralized bone SBC: straumann® _BoneCeramic

osteoid: green staining

Polarized image displays osseointegration of

Straumann® _{BoneCeramic particle in lamellar type}

of bone, 6 months post augmentation Image by Prof. Dr. Z. Artzi. Paragon staining, original magnification X 600

Reproduction authorized by Clin. Oral Impl. Res Image by Prof. Dr. J. Froum. Stevenel´s blue and Van Gieson´s picro fuchsin, magnification X 200 Reproduction authorized by International Journal of Periodontics & Restorative Dentistry

Composition of regenerated tissue 6–7 months post augmentation

3,4,5 _{see studies overview on page 8}

mean bone mineral area, 6 and 9 months post augmentation 58% 42% 21.6% 51.8% 26.6% 19.8% 42.5% 37.7% 0 10 20 30 40 50 60 70 90 80 100 % Residual ridge Straumann ®

BoneCeramic Bovine bonemineral

Percentage of augmented area

0 10 20 30 40 50 60 % 6 months 9 months

5 1.

2.

bone volume restoration and preservation

for the desired esthetiC outCome

In a prospective randomized con-trolled clinical study Straumann®

BoneCeramic in combination with autogenous bone has been observed to successfully restore bone volume in dehiscence-type defects6_.

equivalent defect fill as with bovine bone mineral 6 months after augmen tation6_.

Significantly higher bone gain with Straumann® _BoneCeramic

compared to autogenous bone alone in interproximal intrabony defects7_.

equivalent vertical bone growth and relative bone gain compared to bovine bone mineral 12 months post augmentation7_.

In a prospective randomized con-trolled clinical study, Straumann®

BoneCeramic, in tooth extraction sockets, successfully supported ridge dimensions preservation8_.

statistically significant less reduction in the bucco­lingual ridge dimension with straumann® _{BoneCeramic than with} bovine bone mineral, 8 months post augmentation.

equivalent width of the buccal and palatal/lingual bone plate and equivalent distance (height) of the alveolar bone crest at the mesial­ and distal­central aspects of the socket relative to the CeJ of neighboring teeth, with straumann® _BoneCeramic compared to bovine bone mineral, 8 months post augmentation8_.

Dehiscence type defect before and 6 months after

augmentation with Straumann® _BoneCeramic

Image by Dr. N. Van Assche

Periapical radiograph before treatment and 12 months after augmentation procedure Image by Prof. Dr. G.-G. K. Zafiropoulos Reproduction authorized by J. Periodontology

1. Extraction socket filled with Straumann®

BoneCeramic

2. Bone volume restoration 8 months post augmentation

Images by Dr. N. Mardas and Prof. N. Donos

6

straumann

_boneceramic

exCellent handling, reproduCiBle quality

straumann® _{BoneCeramic is a fully synthetic and biocompatible product. its manufacturing process features homogeneous} phase distribution and batch­to­batch consistency.

straumann® _{BoneCeramic rapidly absorbs fluids, forming a granular putty. the wetted granules adhere to the applica­} tion instrument and sub sequently fit the bony defect nicely. straumann® _{BoneCeramic mixes well with sterile saline solution,} autogenous blood and bone.

Art. No. Article Dimensions

070.203 straumann® _{BoneCeramic 400 – 700 granule size: 400 – 700 microns}

unit size: 0.25 g volume: approx. 0.3 ml

070.204 straumann® _{BoneCeramic 500 – 1000 granule size: 500 – 1000 microns}

unit size: 0.5 g

volume: approx. 0.95 ml

070.205 straumann® _{BoneCeramic 500 – 1000 granule size: 500 – 1000 microns}

unit size: 1 g

volume: approx. 1.9 ml

7

HA TCP

technical sheet

Straumann® _{BoneCeramic is a fully synthetic bone graft substitute indicated for filling and/or augmenting}

intraoral/maxillofacial osseous defects:

bony defects of the alveolar ridge p

tooth extraction sites p

sinus floor elevation p

intrabony periodontal osseous defects and furcation p

Optimized morphology

With its optimized porosity, straumann® _{BoneCeramic is designed to favour vascularisation, osteoblast migration and bone} deposition. high porosity and minimum amount of material leave maximum space for new bone.

Gradual resorption

straumann® _{BoneCeramic consists of hydroxylapatite and ­tricalcium phosphate in a very homogenous com posite.} ­tricalcium phosphate resorbs faster than hydroxylapatite, becoming replaced by natural bone. hydroxy lapatite prevents excessive resorption and preserves bone volume for a successful esthetic result9_.

Reproducible quality and safety of synthetic products

straumann® _{BoneCeramic is a fully synthetic and biocompatible material. it mixes well with sterile saline solution,} autogenous blood or bone. straumann® _{BoneCeramic rapidly absorbs fluids, forming a granular putty which adheres} to the application instrument and fits the bony defect nicely.

60 % hydroxylapatite p

40 %

p _{­tricalcium phosphate}

Biphasic calcium phosphate

High porosity

Granule dimensions

Excellent wettability and handling

total porosity: 90 % p interconnected pores p pores size: 100–500 µm p

Two available granule sizes

400–700 µm p

500–1000 µm p

absorbs fluids, forming a granular putty p

adheres to the application instrument p

nicely conforms to the bony defect p

8

1 schwarz f. et al. guided bone regeneration at

dehiscence­type defects using a biphasic hydroxyapatite + beta tricalcium phosphate (Bone Ceramic®_{) or a collagen­}

coated natural bone mineral (Biooss Collagen®_).

an immunohistochemical study in dogs. international Journal of oral & maxillofacial surgery 2007:36:1198–1206.

2 schwarz f. et al. immunohistochemical characterization of wound healing at two different bone graft substitutes. a pilot study in dogs. data on file

3 Cordaro l. et al. maxillary sinus grafting with Bio­oss or straumann BoneCeramic: histomorphometric results from a randomized controlled multicenter clinical trial.

Clin. oral. impl. res. 2008; 19: 796–803

4 froum s. J.et al. histomorphometric comparison of a bipha­ sic bone ceramic to anorganic bovine bone for sinus aug­ mentation: 6­ to 8­ month postsurgical assessment of vital bone formation. a pilot study.

int. J. periodontics restorative dent. 2008; 28: 273­281

5 artzi Z. et al. histomorphometric assessment of bone forma­ tion in sinus augmentation utilizing a combination of autog­ enous and hydroxyapatite/biphasic tricalcium phosphate graft materials at 6 and 9 months in humans.

Clin. oral impl. res. 2008; 19: 686­692

6 van assche n. et al. BoneCeramic as alternative for Bio­ oss in the treatment of bony dehiscencies along implants. eao 2007. data on file (study Cr 04/05)

7 Zafiropoulos g.­g. K. et al. treatment of intrabony defects using guided tissue regeneration and autogenous spongiosa alone or combined with hydroxyapatite/beta tricalcium phosphate bone substitute or bovine­derived xenograft. J. periodontol. 2007; 78: 2216­2225

8 mardas n. et al. socket preservation with synthetic bone substitute or a bovine xenograft.

iadr 2008. data on file (study Cr 03/05)

9 Jensen s. s. et al. evaluation of a novel biphasic calcium phosphate in standardized bone defects.

a histologic and histomorphometric study in the mandibles of minipigs.

Clin. oral. impl. res. 2007;18: 752­760

studies

straumann

_BoneCeramic

Reference Study Type Indication

preclinical canine study

p

6 animals, 24 dehiscence­type defects

p

split mouth design

p

use of a gBr resorbable membrane

p

dehiscence­ type defects

preclinical canine study

p

split mouth design

p

6 animals, 24 dehiscence­type defects

p

use of a gBr resorbable membrane

p

dehiscence­ type defects

prospective, randomized, multicenter clinical

p

study

37 patients, 48 sinus floor elevation procedures

p

use of a gBr resorbable membrane

p

sinus floor elevation

prospective, blinded, randomized,

p

controlled clinical study split mouth design

p

12 patients, 21 sinus floor elevation procedures

p

use of a gBr resorbable membrane

p

sinus floor elevation

prospective clinical study

p

28 patients, 28 sinus floor elevation procedures

p

in combination with autogenous bone

p

use of a gBr resorbable membrane

p

sinus floor elevation

prospective, randomised controlled clinical

p

study

split mouth design

p

14 patients, 28 extraction sockets

p

in combination with autogenous bone

p

use of a gBr resorbable membrane

p

dehiscence­ type defects

single masked, non randomized, case­control

p

clinical study

65 patients, 93 intrabony defects

p

in combination with autogenous bone

p

use of a gBr resorbable membrane

p

periodontal intrabony defects

prospective, single blind, randomized, con­

p

trolled clinical study

26 patients, 26 extraction sockets

p

use of a gBr resorbable membrane

p

alveolar ridge dimensions preservation

preclinical study in minipigs

p

16 animals, 128 mandibular bony defects

p

use of a non resorbable membrane

p

mandibular bony defects

www.straumann.com

three reasons to choose straumann

_BoneCeramic

the vitality you need around your implants

bone volume restoration and preservation for the desired esthetic outcome excellent handling, reproducible quality straumann products are C e marked 09/08 152.319/e Ba 31109

© institut straumann ag, 2009. all rights reserved.

straumann® _{and/or other trademarks and logos from straumann}® _{that are mentioned herein are the trademarks or registered trademarks of straumann}