RELIABLE WHEN IT COUNTS. The unique collagenase-resistant membrane protects bone graft and supports treatment success even when exposed 4

Transcription

1 RELIABLE WHEN IT COUNTS 1

2 RELIABLE WHEN IT COUNTS RESISTANT TO EXPOSURE The unique collagenase-resistant membrane protects bone graft and supports treatment success even when exposed 4 RELIABLE BARRIER Barrier function up to 6 months optimizes bone regeneration 1-3 PROVEN SUPPORTED BY: >100 * PUBLICATIONS IN PEER-REVIEWED JOURNALS Documented biocompatibility and proven clinical performance as bases for safe application and predictable therapy results 2,5 OSSIX PLUS is a cross-linked collagen membrane consisting of highly purified collagen (type I) of porcine origin. This membrane is cross-linked differently than native or other cross-linked collagen membranes resulting in a unique resistance to collagenases. Therefore, OSSIX PLUS features a significantly longer barrier function than conventional collagen membranes and is at the same time highly biocompatible, comparable to native collagen membranes. OSSIX PLUS has unique characteristics due to the patented GLYMATRIX technology (cross-linking by means of the natural sugar), mimicking endogenous physiological collagen cross-linking processes. 2 * GLYMATRIX technology based membranes

3 RESISTANT TO EXPOSURE REGEDENT AG OSSIX PLUS UNIQUE COLLAGENASE-RESISTANT MEMBRANE PROTECTS BONE GRAFT AND SUPPORTS TREATMENT SUCCESS EVEN WHEN EXPOSED Compared to non-resorbable membranes, exposure of conventional resorbable collagen membranes does not usually result in a serious infection. 7 Nevertheless, bacterial contamination of the membrane results in its faster degradation. This leads to ingrowth of soft tissue into the former defect and more likely to infiltration of the augmentation substrate with inflammatory cells. In the worst case, this ends with infection of the graft strongly compromising the desired result of the bony regeneration. Due to the significant loss of graft volume, the aesthetic result of the treatment is jeopardized. 4,8,9,10 These processes are particularly pronounced when using membranes with short barrier times. 8,10 Due to its sugar cross-linked collagen fiber network, OSSIX PLUS features a markedly increased resistance to degradation by bacterial collagenases compared to native collagen membranes. This was impressively demonstrated in a clinical study. 4 After exposure to the oral environment for 10 days, the complete OSSIX PLUS membrane body was still intact whereas native (NCM) and chemically cross-linked membranes (CCM) had already been significantly degraded. This unique characteristic of sugar cross-linked membranes has a significant clinical impact. In a clinical trial, the performance of a sugar cross-linked membrane was compared to a standard native collagen membrane and a non-resorbable eptfe-membrane for generating new bone after augmentation of dehiscence defects around simultaneously inserted dental implants. 7 The augmentative result in case of a wound dehiscence was found to be better in a statistically significant way when using a sugar cross-linked membrane compared to a native collagen or a PTFE membrane. MEMBRANE INTEGRITY Median Score (Likert Scale) * GAIN OF AUGMENTATION POST DEHISCENCE % Bone Volume OSSIX PLUS NCM CCM OSSIX PLUS is significantly more stable to bacterial degradation than native (NCM) or chemically cross-linked membrane (CCM). *Statistically significant difference between OSSIX PLUS and two other membranes. Width * * Height eptfe NCM RCLM After 6 months, Ribose cross-linked membranes (RCLM) show significantly higher amounts of newly formed bone volume around dental implants compared native (NCM) or chemically cross-linked membrane (CCM) after post-surgical dehiscences. 3

4 RELIABLE BARRIER BARRIER FUNCTION UP TO 6 MONTHS OPTIMIZES BONE REGENERATION The OSSIX PLUS membrane is cross-linked in a physiological process involving natural sugar (glycation). This process allows generation of a barrier membrane with a long resorption profile of up to 6 months without losing the excellent biocompatible characteristics of highly purified porcine collagen. 11 GAIN OF AUGMENTATION Gain in Bone Volume (mm) 3,00 2,00 1,00 0,00 Bone Height NCM RCLM Bone Width Ribose cross-linked collagen membranes (RCLM) shows significantly higher amounts of newly formed bone volume around dental implants compared to a native collagen membrane (NCM) 6 months after augmentation. *Statistically significant difference between RCLM and NCM. In a comparative clinical trial, Friedmann et al. tested the clinical performance of a Ribose cross-linked collagen membrane versus a standard native collagen membrane for generating new bone after augmentation of dehiscence defects around simultaneously inserted dental implants. 12 After 6 months, the Ribose cross-linked group showed in a statistically significant way more bone gain both in vertical and in horizontal dimension. Especially in challenging indications, the OSSIX PLUS membrane appears to have a superior regenerative potential. Thanks to its long time barrier function, OSSIX PLUS allows bone to fully regenerate. 12 As shown in various peer-reviewed scientific publications, bone tissue needs sufficient time to regenerate at an optimal level. 13,14 INDICATIONS OSSIX PLUS DESIGNED FOR SUPERIOR TREATMENT RESULTS The OSSIX PLUS biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: 1. Ridge augmentation for later implant insertions 3 2. Simultaneous ridge augmentation and implant insertions Ridge augmentation around implants inserted in delayed extraction sites Ridge augmentation around implants inserted in immediate extraction sites Alveolar ridge preservation consequent to tooth (teeth) extraction(s) Over the window in lateral window sinus elevation procedures In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved In intra bony defects around teeth For treatment of recession defects, together with coronally positioned flap In furcation defects in multi rooted teeth. 3

5 PROVEN DOCUMENTED BIOCOMPATIBILITY AND PROVEN CLINICAL PERFORMANCE AS BASES FOR SAFE APPLICATION AND PREDICTABLE THERAPY RESULTS Soft-tissue healing after augmentations with OSSIX PLUS membranes is comparable to native collagen membranes. 2 In a comparative clinical trial, bone augmentation of dehiscence defects around simultaneously inserted dental implants using either OSSIX PLUS or a native collagen membrane was tested. The incidence of wound dehiscences after augmentations with OSSIX PLUS was in the same range as for the control group using the native collagen membrane. 15 CELL VIABILITY HUMAN PERIOSTEAL CELLS Proliferation % NCM OSSIX PLUS CONTROL In a cell culture study, the ability of different collagen membranes to support and promote proliferation of human periosteal cells was investigated. It could be confirmed that OSSIX PLUS membrane shows biocompatibility comparable to native collagen membranes known for their excellent tolerability by the human body. 16 Sugar cross-linked membranes have been clinically used worldwide for more than 16 years and hundreds of thousands of patients have been treated. More than 100 scientific publications impressively document the biological properties and the associated clinical performance of sugar cross-linked membranes. OSSIX PLUS features cell viability comparable to native collagen membrane. SUPPORTED BY: >100 * PUBLICATIONS IN PEER-REVIEWED JOURNALS * GLYMATRIX technology based membranes 5

6 SOCKET PRESERVATION Clinical case by courtesy of Prof. Dr. Anton Friedmann (Germany) PRE-OP Tooth 16 not worth preserving with periapical granuloma at palatal root (left). Post closure of socket with OSSIX PLUS membrane only (without bone graft material) and repositioning of flaps using cross-seam suturing technique. 3 DAYS POST-OP Inflammation-free intact membrane structure, early wound closure (left). 7 DAYS POST-OP Advanced wound closure already visible, sutures removed (right). 21 DAYS POST-OP Complete wound closure (left). 6 MONTHS POST-OP Completely healed keratinised gingiva conditions (right). POST FLAP PREPARATION Completely consolidated alveolar ridge with buccal residues of ossified membrane (left). 6 POST INSERTION OF IMPLANT Sufficient bone available in buccal and apical dimensions (right).

7 VERTICAL AUGMENTATION USING THE TENT-POLE TECHNIQUE REGEDENT AG OSSIX PLUS Clinical case by courtesy of Dr. Peter Randelzhofer (Germany) OP Massive vertical bone defect in region #22. Placement of an osteosynthesis screw as tent-pole (left). Defect was filled with slow-resorbing bone graft material and covered labially and palatinally with OSSIX PLUS membrane (right). 5 MONTHS POST-OP Situation at re-entry shows a stable and completely regenerated alveolar ridge with vital bleeding bone structure. Remnants of the OSSIX PLUS membrane were still clearly visible and partially integrated in the newly formed bone. The implant could be placed in the prosthetically correct position in sufficient amount of vital bone without additional augmentation. FOLLOW-UP Further healing indicates stable tissue structures after implantation (left) and at time of installation of gingiva former (right). 7

8 AVAILABLE PRODUCTS ARTICLE NUMBER MEMBRANE SIZE OXP1525 OXP2530 OXP mm x 25 mm 25 mm x 30 mm 30 mm x 40 mm REFERENCES 1. Zubery Y et al. J Periodontol 2008;79(6): (Ossification of a collagen membrane cross-linked by sugar: a human case series) 2. Scheyer ET, Mc Guire MK. Clin Adv Periodontics 2015;5(3): (Evaluation of Premature Membrane Exposure and Early Healing in Guided Bone Regeneration Peri-Implant Dehiscence and Fenestration Defects ith a Slowly Resorbing Porcine Collagen Ribose Cross-Linked Membrane: A Consecutive Case Series Scheyer) 3. Cook DC, Mealey BL. J Periodontol 2013; 84(5): (Histologic Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Two Different Xenograft Protocols) 4. Klinger et al. Clin Oral Impl Res 2010;21, (In vivo degradation of collagen barrier membranes exposed to the oral cavity) 5. Zubery Y et al. J Periodontol 2007;78(1): (Ossification of a novel cross-linked porcine collagen barrier in guided bone regeneration in dogs) 6. Brkovic BMB et al. Clin Oral Invest 2012(16): (Beta-tricalcium phosphate/type I collagen cones with or without a barrier membrane in human extraction socket healing: clinical, histologic, histomorphometric, and im- munohistochemical evaluation) 7. Moses O et al. Clin Oral Implants Res 2005;16: (Healing of dehiscence-type defects in implants placed together with different barrier mem branes: a comparative clinical study) 8. Friedmann A et al. J Clin Periodontol 2011;38: ( Randomized controlled trial on lateral augmentation using two collagen membranes: morphometric results on mineralized tissue compound) 9. Oh TJ et al. Clin Oral Impl Res 2003(14):80 90 ( Comparative analysis of collagen membranes for the treatment of implant dehiscence defects) 10. Friedmann A et al. Clin Oral Invest 2015;19(7): (Tissue reactions after simultaneous alveolar ridge augmentation with biphasic calcium phosphate and implant insertion histological and immunohistochemical evaluation in humans) 11. Zubery Y et al. J Periodontol 2008;79(6): (Ossification of a collagen membrane cross-linked by sugar: a human case series) 12. Friedmann A et al. J Clin Periodontol 2011;38: (Randomized controlled trial on lateral augmentation using two collagen membranes: mor phometric results on mineralized tissue compound) 13. Tal H et al. Clin Oral Implants Res 2008;19(8):760-6 (Cross-linked and non-cross-linked collagen barrier membranes disintegrate following surgical exposure to the oral environment: a histological study in the cat) 14. Tal H et al. Clin Oral Implants Res 2008;19(3): (Long-term bio-degradation of cross-linked and non-cross-linked collagen barriers in human guided bone regeneration) 15. Lee DW et al. Journal of Oral Implantology 2015;41(4): (The role of two different collagen membranes for dehiscence defect around implants in humans) 16. Warnke PH et al. Clin Oral Impl Res 2009;20: (Tissue engineering of periosteal cell membranes in vitro) OSSIX PLUS is a registered brand and manufactured by Datum Dental Ltd., 1 Bat Sheva Street, Lod Israel. CE 0482 Art EN, REGEDENT AG Zollikerstrasse 144 CH-8008 Zürich Tel: +41 (0) info@regedent.com