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BioXclude Primer (Holtzclaw D, JIACD, Feb 2017)

BioXclude

BioXclude is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery. Since its introduction in 2010, Snoasis Medical has distributed over 70,000 grafts of BioXclude. This allograft represents a paradigm shift in regenerative technology. Its unique physical and biological properties provide the benefits of a growth factor and an occlusive barrier.

Product Description

Tissue cross section.

The tissue used in BioXclude is obtained from consenting mothers who donate their placentas after elective caesarian section delivery. The amnion chorion tissue is processed using Purion^®, a patented, tissue processing technology designed to cleanse and maintain the delicate structures of the tissue. Following processing and dehydration, the allografts are packaged and terminally sterilized (SAL 10^-6). This processing methodology allows for retention of the biological factors found in native amnion chorion tissue.

Growth Factor Properties

BioXclude has been shown to contain over 250 biological factors, extracellular matrix (ECM) proteins, cytokines, interleukins, and tissue inhibitors of metalloproteinase (TIMP), known to play a role in wound healing and reducing inflammation^1–4. In vitro, in vivo, and clinical research demonstrate the following benefits:^1-3,5-9

Rapid wound closure when left exposed
Cellular occlusive with rapid sealing of protected space
Hastens flap reattachment
Allows for rapid vascular growth
Shown to recruit mesenchymal stem cells
Suppresses inflammation

Occlusive Barrier Properties

The physical properties of BioXclude allow clinicians to avoid many of the drawbacks associated with traditional collagen and synthetic membranes, which can help simplify the procedure, allow for less invasive surgery, and reduced chair time.^5,7,10

A processed, sterilized graft of BioXclude.

No trimming required
Extremely thin; does not add meaningful bulk to the site
Lacks rigidity and is self-adherent with excellent adaption
Can be placed UP or DOWN and fold onto itself
Can be placed over exposed roots and grafted implants
May be placed over or under other membranes, meshes or palatal tissue

Applications

The unique biologic and physical properties of amnion and amnion chorion (BioXclude) allograft allow it to be used as a wound covering for a multitude of dental implant / periodontal / oral maxillofacial applications which include^{5, 9, 11-17}:

Socket Preservation
Implants
Peri-Implantitis
Periodontal

Ridge Augmentations
Sinus/Flap Perforations
Oral Wounds
Growth Factor


Site Presentation^A BioXclude left exposed over #20 site grafted with Maxxeus 70/30.	Excellent healing at 9 days with granulation tissue covering exposed portion of BioXclude.	Healing at 7 weeks with healthy gingival tissue covering the site.	At 6 months, implant is surrounded with a wide zone of attached keratinized tissue.


Implant^B 84 year old male with large buccal defect on #29; implant placed.	Once adapted over grafted implant, BioXclude adds minimal bulk.	Great contour of the gingiva at 4 months.	Reentry at 4 months reveals excellent new bone formation.


Peridontal^A Smoker; #18D 11mm PD, #19B 8mm PD (grade 2 furc), #19M 7mm PD.	BioXclude placed over exposed roots and defects grafted with Maxxeus 70/30.	At 12 months, the gingival margin is maintained with a small gain in root coverage.		30 month radiograph shows defect resolution; #18D 4mm PD, #19B 3mm PD, #19M 3mm.

Sizing, Storage and Ordering

Using a larger piece makes placement much easier as it can fold over itself and/or multiple pieces overlap one another. The allograft also contains biological factors to aid healing. For these reasons, clinicians are encouraged to order larger sizes of BioXclude than they would when purchasing a traditional barrier membrane. BioXclude contains biological factors to aid healing. For this reason, and because it is thin, adaptable and excess material can be folded onto itself, clinicians are encouraged to use the entire piece, or in some cases, a bigger piece depending on the procedure. BioXclude is for single use only and is available in six sizes.

8mm x 8mm 12mm x 12mm 10mm x 20mm 15mm x 20mm 15mm x 25mm 20mm x 30mm
BioXclude is to be stored at ambient temperature. To place an order, please call Snoasis Medical at 1-866-521-8247 or download an order form by visiting the Order page of this website.

References / Credits / Abbreviations

[1] Koob T, Rennert R, Zabek N, et al. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J 2013: doi: 10.1111/iwj.12140.

[2] Koob T, Li W, Gurtner G et al. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vas Cell 2014; 4(10): doi:10.1186/2045-824X-6-10.

[3] Koob T, Zabek N, Massee N, et al. Properties of dehydrated human amnion/chorion composite grafts: implications for wound repair and soft tissue regeneration. J BioMed Mat Res Part B 2014:00B:000-000.

[4] Xenoudi P, Lucas M, Chlipala E, et al. Comparison of porcine and amniotic resorbable collagen membranes using H&E staining and immunohistochemistry. Manuscript in Preparation. Data on file at Snoasis Medical.

[5] Holtzclaw D, Toscano N. Amnion chorion allograft barrier: indications and techniques update. J Imp Adv Clin Dent 2012; 4(2):25-38.

[6] Holtzclaw D, Toscano N. BioXclude™ placental allograft tissue membrane in combination with bone allograft for site preservation: A Case Series. J Imp Adv Clin Dent 2011; 3(3):35-50.

[7] Wallace W, Cobb C. histological and computed tomography analysis of amnion chorion membrane in guided bone regeneration in socket augmentation. J Imp Adv Clin Dent 2011; 3(6): 61-72.

[8] Holtzclaw D, Hinze F, Toscano N. Gingival flap attachment healing with amnion-chorion allograft membrane: A controlled, split mouth case report replication of the classic 1968 Hiatt study. J Imp Adv Clin Dent 2012; 4(5):19-25.

[9] Holtzclaw D, Toscano N. Amnion–chorion allograft barrier used for guided tissue regeneration treatment of periodontal intrabony defects: A retrospective observational report of 64 patients. Clin Adv Perio 2013; 3(3):131- 137.

[10] BioXclude Handling Instructions, PR091301v04. Data on File at Snoasis Medical.

[11] Holtzclaw D, Cobb C. Extraction site preservation using new graft material that combines mineralized and demineralized allograft bone: a case series report with histology. Compendium. Feb 2014; 107-112.

[12] Niknejad H, Peirovi H, Jorjani M, et al. Properties of the amniotic membrane for potential use in tissue engineering. Euro Cells Mat 2008; 15: 88-89.

[13] Kesting M, Wolff KD, Nobis C, et al. Amniotic membrane in oral and maxillofacial surgery. Oral Maxillofac Surg 2012; Epub Dec 16.

[A] Dan Holtzclaw, DDS, MS, Austin, TX

[B] Robert J Miller, DMD, Plantation, FL

[ECM] Extracellular Matrix

[PDGFα] Platelet-Derived Growth Factor-Alpha

[PDGFβ] Platelet-Derived Growth Factor-Beta

[TGFβ] Transforming Growth Factor-Beta

[bFGF] Basic Fibroblast Growth Factor

[EGF] Epidermal Growth Factor

[IL-1ra] Interleukin-1 Receptor Antagonist

[IL] Interleukin

[VEGF] Vascular Endothelial Growth Factor

[GCSF] Granulocyte-Colony Stimulating Factor

[PLGF] Placenta Growth Factor

[TIMP] Tissue Inhibitor of Metalloproteinase

[Maxxeus 70/30] Maxxeus cortical mineralized / demineralized allograft bone 70/30 blend (Community Tissue Services, Dayton, OH)