BioXclude Technology Presentation

Transcription

1 BioXclude Technology Presentation

2 Amnion-Chorion Avascular tissue comprising the inner most layer of placenta separating the mother and fetus Adapted from Boyd (1970)

3 Amniotic Tissue Amniotic fluid Maternal decidua Amnion Layer Epithelium Basement Membrane Compact layer Fibroblast layer Intermediate (spongy) layer Chorion Reticular layer Basement Membrane Trophoblasts Extracellular Matrix Composition Collagen types III, IV, V; laminin, fibronectin, nidogen Collagen types I, III, V, VI; fibronectin Collagen types I, III, VI; nidogen, laminin, fibronectin Collagen type I, III, IV; proteoglycans Collagen types I, III, IV, V, VI; proteoglycans Collagen types VI; fibronectin, laminin Adapted from: Niknejad, H et, al. European Cells and Materials 2008; 15:88-99

4 Overview - Introduced in Composed of dehydrated human amnion and chorion tissue Purion processing - Room temperature storage - Five year shelf life Uses as a Wound Covering in Dental Surgery - Grafted extraction sockets - Bone defects around teeth and implants - Over block grafts, ridge splits, and covering the sinus lateral window - Sinus and flap perforations - Over titanium mesh or stiffer barriers in larger ridge augmentations - Mild gingival recession - Adhesion barrier in TMJ surgery - Oral mucosa surgical defects

5 Scientific Attributes of Amniotic Tissue Literature Review Reviewed over 150 papers (27 met inclusion criteria) Findings: Possesses four unique attributes (1) Immunoprivileged No foreign body inflammatory response No reported adverse events ever reported (2) Anti-Inflammatory Modulates inflammation: decreased patient pain Downregulates inflammatory cell recruitment (3) Anti-Bacterial Reduces risk of infection Tight seal formed after placement precludes bacteria (4) Accelerates Healing Cytokines / Growth Factors (PDGF, VEGF, FGF ) Cell adhesion proteins (fibronectin, laminin, laminin-5 ) Chen E, Tofe A. J Implant Adv Dent 2009; 2(3):67-75.

6 Tissue Processing and Procurement Procurement - Placenta obtained from consenting donor during elective caesarian section. - Compliance with AATB and FDA allograft tissue standards. Purion Processing Technology - First used in ophthalmology (2006) - Today used to treat chronic wounds, plastics, sports medicine, and many others - Cleanses and maintains delicate tissue structure - Dehydrates and embosses graft - Terminally sterilized (10-6 SAL) - Retains active growth factors, cytokines, and extracellular matrix architecture

7 Chronic Wound (use not in dental, GF potential) 2 Presented at ER 10 Days postop debridement Case Overview Preop wound size was 18.75cm 2 ; amputation scheduled; Epifix was last resort. 30% wound area reduction at 7 days Additional 15% area reduction at 14 days Additional application at 14 days Wound closed at 28 days. At 3 months, patient is walking with custom molded show. 42 Days postop Courtesy of MiMedx Group PR081301v01

8 Purion Processing Technology 3 Retains Biological Factors - Growth factors - Cell adhesion proteins - Interleukins - Tissue inhibitors of metalloproteinases Cellular Activity - Migration of human mesenchymal stem cells in-vitro - Recruitment of mesenchymal progenitor stem cells in-vivo Non-Dental Trade Names - EpiFix (wound care) - AmnioFix (sports medicine) - Many others Koob T et al. Int Wound J 2013; Online:1-8 AmnioFix Scientific and Clinical Compendium, March MiMedx Group Cytokines Present in Amnion/Chorion Tissue Cytokine Fresh Purion Processed PDGF-AA PDGF-BB TGF-a TGF-b bfgf EGF VEGF IL-10 IL-4 PIGF TIMP-1 TIMP-2 TIMP-4 PR081306v02

9 Site Preservation 4 Tooth #3 BX in Place* Site Closure 96 Hours 10 Days 3 Months * Grafted FDBA Holtzclaw D, Toscano N. J Implant Adv Clin Dent 2011; 2(6):49-55 PR061316v01

10 Site Preservation (Moderate Buccal Defect) 5 Osseous Defect BioXclude Folded Over Itself* Site Closure 3 Months Implant Placement Pre-Op / 3 Month Post-Op * Site grafted with FDBA Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR071302v02

11 Site Preservation (Small Buccal Defect) 6 Buccal Dehiscence Defect Extraction Socket BioXclude Over FDBA Non-Primary Closure 3 Months Pre-Op / 3 Mo Post-Op Courtesy of Dan Holtzclaw, DDS, MS, Austin TX

12 Site Preservation (Moderate Buccal Defect) 7 Defect on #19 Site Closure* 10 Days 8 Weeks 3 Months Excellent Tissue Profile * Second piece of BioXclude was placed over the top covering crest and lingual aspect Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR061323v02

13 IN VITRO ANALYSIS OF ANTIMICROBIAL ACTIVITY BETWEEN AN AMNION-CHORION MEMBRANE AS COMPARED TO A COLLAGEN MEMBRANE Haroon Ashraf DDS, Kerri Font DDS,MS, Michael Schurr PhD, Mark Lucas DDS,MS, Charles Powell DDS,MS University of Colorado School of Dental Medicine Postgraduate Periodontics Abstract # ABSTRACT Materials Median Microbial Count Purpose: In surgical procedures, the selection of adjunctive biomaterials may amplify the innate regenerative potential within a wound and enhance the clinical outcome. The purpose of this study is to evaluate wound biomodification by assessing antimicrobial properties present within a human derived composite amnion-chorion membrane (ACM). Allograft Amnion Chorion Porcine Collagen 4.4 ± ± 0 Material & Methods: Membranes analyzed in the study were the human ACM BioXclude (Snoasis Medical) and the porcine derived collagen membrane BioGide (Geistlich). Paper discs were used as a positive control along with paper discs containing tetracycline (TCN) at a minimum bactericidal concentration (MBC) of 62 µg/ml as a negative control. Three bacterial species were used in the study: Aggregatibacter actinomycetemcomitans (A.a.), Streptococcus mutans (S.m.), and Streptococcus oralis (S.o.). The same number of colony forming units per milliliter (CFU/mL) for each bacterial species was inoculated on each membrane and control discs. Samples were grown over brain heart infusion (BHI) agar medium under optimal conditions. Discs from each group were removed at 12 and 24 hours and sonicated to remove the bacteria off the membranes. A serial dilution was performed to quantify bacterial growth in triplicate by counting the CFU/mL present. A Wilcoxon signed-rank test was performed to compare any differences between growths. Results: Three in vitro trials were conducted. The ACM inhibited growth at all time points, with all bacterial strains, identical to the negative control TCN discs. The collagen membrane and positive paper controls did not inhibit growth of any of the bacterial species throughout the 24-hour study period. Bacterial Growth Conclusion 0.7 BioXclude - FGF (40x) 2.4 BioXclude - PDGFa (40x) Figure 1. Bacterial growth following removal of attempted A.a. culture from ACM (left half of plate) and collagen membrane (right half of plate) at 24 hours following serial dilution. Figure 2: Median microbial count for each membrane and bacteria at 12 hours. 4.2 ± ± 0 Figure 3: Median microbial count for each membrane and bacteria at 24 hours. P < 0.05 for microbial growth on ACM and negative control vs. either collagen membrane or positive control. 3.2 ±1.1 It was determined that the ACM was as bactericidal as paper discs inoculated with TCN at its MBC. The collagen membrane does not appear to have anti-microbial properties due to its support of the bacterial growth similar to the positive control discs. 3.0 ± 0

14 Site Preservation (heavy smoker) 8 Tooth #14 BioXclude Exposed* 2 Weeks 10 Weeks Restored (15 Months) Restored (15 Months) * Grafted with FDBA Courtesy of Muyeenul Hassan, BDS Indiana University School of Dentistry, Graduate Periodontics PR061320v01

15 Double Extraction Site Preservation 9 Extracted #18 and #19 Allograft blend placed BioXclude placed Non-primary closure 14 week re-entry Implants placed Courtesy of Dan Holtzclaw, DDS, MS, Austin, TX PR051401v01

16 Site Preservation (Moderate Buccal Defect) 10 Pre-op radiograph Missing buccal wall BioXclude over FDBA Site closure 1 week post-op 4 month radiograph Courtesy of Muyeenul Hassan, BDS, MS, Univ of Detroit Mercy School of Dentistry PR031402v01

17 Benefits of Combined Amnion-Chorion Allograft BioXclude is the only product in the dental market with combined Amnion- Chorion BioXclude contains 4 to 5x more growth factors than amnion only allografts Chorion layer accounts for over 80% of the growth factors found in BioXclude BioXclude is 4 to 5x thicker than amnion only allografts

18 Aids in Formation of Clinical Attachment 12 Full maxilla flap reflection followed by scaling and root planning and osseous contouring. BioXclude placed over only one side the exposed bone. Reattachment measured by force needed to pull suture separating the gingiva. Tensile Strength (in grams) Required to Separate Gingival Flap 72 hours 1 week 2 weeks 3 weeks Control (nothing) ,600 2,100* BioXclude side 325 1, * 2,200* * Sutures pulled through without flap displacement Holtzclaw D et al. J Imp Adv Clin Dent 2102; 4(5); PR061315v01

19 Ridge Split 13 Pre-Op BioXclude Placement Site Closure 4 months* 6 Months** 10 Months * 7.5 mm increase in ridge width (5.5 mm 13 mm) ** Increase zone of attached gingiva and partial root coverage on tooth #21 Childers G. Retrieved from May 2012 PR061333v01

20 Implant Repair 14 Pre-Op Implant #20 Pre-Op Radiograph Defect BioXclude in Place* 12 Month Post-Op 12 Month Radiograph * Grafted with Accell Bone Putty Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR061330v01

21 Immediate Implant 15 Failed implant removal Implant placement Bone graft placement BioXclude placement Post-op view Reentry Courtesy of Robert Miller, DDS, MS, Austin TX PR101301v01

22 Parabiosis Model Stem Cell Recruitment In Vivo Mann et al. J Surg Res, 2015 Tissue samples taken at 3, 7, 14 and 28 days. dhacm Sham GFP Control ADM Villeda S. et al 2014 Implanted dhacms recruited significantly more progenitor cells compared with controls (*P < 0.05) and displayed in vivo SDF-1 expression with incorporation of CD34, CD90 and CD31 + progenitor cells within the matrix.

23 Immediate Implant (Moderate Facial Defect) 17 Buccal defect Implant placement Bone graft placement BioXclude placement Post-op view Reentry Courtesy of Robert Miller, DMD, Plantation, FL PR031401v01

24 Immediate Implant 18 Extraction #8 and #9 Deep V shaped defects present after implant placement FDBA placed Untrimmed BioXclude placed Bone has grown over seated implants at 5 month reentry, Placement of healing abutments Courtesy of Robert J Miller, DMD, Plantation, FL PR021501v01

25 Sinus Lift Membrane Perforation Repair 19 Sinus membrane perforation BioXclude Placement BioXclude adheres to the sinus membrane and seals perforation Lateral sinus window covered with BioXclude Bone allograft placement into sinus cavity Courtesy of Dan Holtzclaw, DDS, MS Austin, TX

26 Sinus Perforation and Elevation 20 Pre-Op CBCT Perforated Sinus Placed BioXclude Sinus Packed w/ Bone Placed Sinus 4 Month CBCT Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR061338v01

27 rhbmp-2 and Titanium 21 Missing Palatal Bone BioXclude Placement* Site Closure (note gingival cleft) 48 Hours Post-Op 10 Days Post-Op Pre-Op 6 Months * Placed over rhbmp-2 + Collagen Sponge and Titanium Mesh Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR061335v01

28 Oroantral Fistula (OAF) Closure year old female with OAF, post extraction #3 CBCT view Defect exposed Defect covered with buccal fat pad and then BioXclude Buccal flap advanced with primary closure 6 week postop Courtesy of Erica Shook, DDS, University of the Pacific, Dugoni School of Dentistry, Dept of Oral & Maxillofacial Surgery, San Francisco, CA PR051501v01

29 Block Graft 23 Defect at #10 Block Graft* BX over Grafted Area 10 Days Post-Op Re-Entry at 7.5 Months Pre-Op and 11 Months * Grafted with Cancellous Allograft Block and FDBA Wang V. Retrieved from January 2013 PR061334v01

30 Ridge Augmentation with rhbmp-2 and Ti 24 Atrophic anterior maxilla rh-bmp2 is placed underneath Ti mesh BioXclude placed over Ti; site closure At 10 days incision line epithelialized over 8 month healing Mesh removed at 10 months, implants placed* Courtesy of Dan Holtzclaw, DDS, MS, Austin, TX CBCT scans at preop and 10 months Healing abutments placed after 4 months * All exposed threads are grafted with Maxxeus 70/30 allograft blend and BioXclude PR021502v02

31 GBR with eptfe and Block Graft 25 Edentulous Site with Ext #24, 25 Allograft Block and Particulate* BioXclude Placed Over eptfe Site Closure 2 Week Post-Op Pre-op CBCT 4 Month Post-op * Both block graft and cortical/cancellous particulate are contain allogenic stem cells Courtesy of Paul Petrungaro, DDS, Chicago, IL PR091303v01

32 Double Membrane - GBR 26 Extraction #23-26, Tenting Screws Placed Grafted with FDBA Collagen Membrane Placed BioXclude Placement Site Closure* Healing at 21 Days * Vestibular dissection into the chin was performed to close the site. Courtesy of Dan Holtzclaw, DDS, MS, Austin TX PR061346v02

33 Ridge Split 27 Pre-Op Grafted w/fdba Placement of BioXclude 10 Days Post-OP Implants at 3 Months Final Restoration * 4.2 mm increase in ridge width at site #28 (2.3 mm 6.5 mm) 4 mm increase in ridge width at site #29 (4.5 mm 8.5 mm) Holtzclaw D, Toscano N. J Implant Adv Clin Dent 2012; 4(2):25-37 PR061331v01

34 Clinical Study - Guided Tissue Regeneration 28 Overview - Single site (private practice) - 12 months results - 64 consecutive patients, 78 sites - Average age = 57 years (range 34-92) - 14 smokers, 2 oral bisphosphonates, 1 rheumatoid arthritis Results - No adverse effects - Excellent early healing - PD: Pre = 8.5 mm, Post = 3.4 mm - CAL: Pre = 9.0 mm, Post = 4.4 mm - PD Improvement: 5.1 mm - CAL Improvement: 4.6 mm Holtzclaw D, Toscano N, Clinical Advances in Periodontics. 2013; 3 (3): PR061329v02

35 Guided Tissue Regeneration 29 Grade III Furcation Buccal Grade III Furcation Lingual BioXclude Over Bone Graft* Site Closure Buccal 6 Month Post-Op Pre-Op / 6 Mo Post-Op * Grafted with Osteocel and rhpdgf Rosen, P. Clinical Advances in Periodontics. 2013; 3 (2): PR061347v02

36 Guided Tissue Regeneration 30 Pre-Op Flap Reflection BioXclude Over Bone Graft* CT Graft Over BioXclude 6 Month Post-Op Pre-Op / 6 Mo Post-Op * Grafted with FDBA and rhpdgf Rosen, P. Clinical Advances in Periodontics. 2011; 1 (2): PR071301v01

37 Guided Tissue Regeneration 31 Pre-Op #30 Defect Grafted with FDBA BioXclude Placed Dry BioXclude Hydrated 16 Month Post-Op Courtesy of Dan Holtzclaw, DDS, MS, Austin TX Probing Depth Pre-Op = 12 mm 3 Months = 3 mm PR061327v01

38 Extraction Socket with Bone Loss 32 Pre-Op 2 Weeks (BX Dehiscence) 5 Weeks 5 Months 5 Months 5 Months Courtesy of Paul Rosen, DMD, MS Yardley, PA

39 Benefits of Amnion Chorion Allograft Contains growth factors which naturally hasten healing No trimming required Reduces inflammation Thinnest, best adapting membrane Can be left exposed to the oral environment Antibacterial Rapid establishment of blood supply Aids in formation of clinical attachment Patient friendly Economical

40 Thank You! PR061344v01