BioXclude Allograft Placental Tissue Membrane in …

1 Bio clude Case Study BioXclude Allograft Placental Tissue Membrane in Combined Regenerative Therapy in the Treatment of a Periodontal Intrabony Defect: A Case Report Paul S. Rosen, DMD, MS, Yardley, PA. Background: Combined regenerative had been trimmed to size was carefully approaches for teeth with intrabony or placed dry over the graft material with furcation lesions have included mem- embossed side facing outward (Figure branes to prevent apical migration of 5). The Membrane was left undistributed both the epithelial cells and connective to hydrate for two minutes and then Tissue into the space, to facilitate contain- carefully moved into final position using ment of the bone replacement graft a wetted microsurgical elevator. Taking along with stabilizing the newly formed special care not to alter the Membrane , clot. This case report documents the use the flaps were coapted over the defect Fig. 1: Preoperative clinical view of amnion chorion Membrane using 6-0 ePTFE sutures with an inter- ( BioXclude ) as a part of combination rupted technique (Figure 6).

2 Regenerative therapy for the treatment of a challenging periodontal intrabony The patient was administered 1 gram of defect. amoxicillin at the end of the surgery along with 800 milligrams of ibuprofen. Case Summary: An otherwise healthy 63 The amoxicillin was continued for 7 days year old female was referred for evalua- at a dose of 875 mg twice daily. Patient tion and treatment on the maxillary left discomfort was managed with ibuprofen second premolar (tooth # 13) (Figure 1). 600 mg, which could be taken every 4-6 Fig. 2: Preoperative radiograph There was both clinical attachment loss hours up to five times daily if needed. and a pocket depth of 8 mm. Radio- The patient was instructed to cease all graphs suggested that the lesion was a brushing and flossing at the treatment combination defect that approached the site for one month to allow for wound apex of this tooth, yet remained as a quiessence and prescribed Chlorhexi- separate clinical entity to the pulp (Figure dine twice daily to manage postoperative 2).

3 The patient was scheduled for surgery plaque. At 2 weeks the sutures were to treat this tooth which had a questio- removed. For the following 2 months, able prognosis. the patient was seen every 2 weeks to maintain thorough plaque debridement Fig. 3: Debridement of defect Prior to surgery, the patient was rinsed and then every other month for up to six with chlorhexidine Sulcular full months post surgery. Thereafter, the thickness flaps were elevated with patient has been seen on 3 month inter- papilla preservation being performed vals for her maintenance care. In addi- between the premolar and first molar. tion to this, endodontics was completed Upon reflection, the defect was debrided due to a periapical lesion that developed of all soft Tissue , followed by scaling and post surgery. root planning using ultrasonic and hand instrumentation (Figure 3). The tooth Results: At two and four weeks, the was detoxified using 250 mg of tetracy- treated site exhibited uneventful early Fig.

4 4: Placement of bone graft cline and 5 milliliters of sterile water healing with soft Tissue response being applied for 2 minutes followed by a quite good as minimal inflammation was through rinsing with sterile water. The demonstrated (Figure 7 and Figure 8). At root surface then had recombinant six months there was a 5 mm gain in platelet-derived growth factor (rhPDGF clinical attachment and probing depth BB) applied to it. Freeze-dried Allograft was reduced to 3 mm (Figure 9). A radio- bone (FDBA) that was rehydrated with graph of the area at six months rhPDGF-BB for several minutes was suggested very good bone fill (Figure 10). gently packed into and slightly overfilled and the area has remained stable at the the defect (Figure 4). BioXclude which one year post-surgical visit. Fig. 5: Placement of BioXclude Bio clude Case Study Discussion: This case report provides inflammatory and anti-bacterial effect evidence that the use of BioXclude , in a during Tissue healing2.

5 Amnion Tissue , combined regenerative approach for the which sits on top of chorion Tissue , treatment of a challenging periodontal possesses a protein-enriched basement intrabony defect, provides for a success- Membrane which includes the presence ful result. Furthermore, this tooth was of laminin-5, a protein with a high affinity critical to retain. If it were lost, an implant for cellular adhesion of gingival epithelia might well require a sinus associated cells3,4. This provides a bioactive matrix procedure for its successful placement. for cellular migration. Fig. 6: Flap closure Adding this tooth into a fixed prosthesis would have required remaking the The physical nature of BioXclude , when already existing bridge into one that had it becomes hydrated, allows for less 8 units. Both of these two options would precise trimming of the Membrane . Once have incurred considerable time and cost hydrated, the Membrane tightly adapts for the patient. The alternative choice of to the underlying bone graft and natu- wearing a removable prosthesis was rally self-adheres to the proximal bony totally unacceptable to this patient.

6 Walls. However, this same characteristic does not allow BioXclude to provide any BioXclude is a processed, dehydrated Fig. 7: Two weeks postoperative and sterilized graft of human amnion and space maintenance capabilities and chorion Tissue . These two layers of Tissue requires it to be placed directly over a represent the inner most lining of the bone replacement graft. BioXclude 's placenta, the part which encloses and relative thinness ( 300 m) and adapt- protects the developing fetus through ability are two of its advantages when term. The Tissue is obtained from donat- there is limited gingival Tissue available ing mothers undergoing elective caesar- to advance over the adapted Membrane . ian section deliveries. Procurement and processing of the Tissue was performed Placental allografts are new to the field of in accordance with stringent regulations periodontology and BioXclude possess Fig. 8: Four weeks postoperative set forth by the Food and Drug Adminis- several key features that make it an tration and the guidelines of the Ameri- attractive option for combined regenera- can Association of Tissue Banking.

7 Tive approaches for osseous lesions. This case report demonstrates the positive Placental Tissue is inherently immuno- benefits for using BioXclude to achieve a privileged and as such, does not elicit a successful clinical regenerative outcome foreign body inflammatory response1. Its for managing a challenging periodontal use has shown to have a local anti- intrabony defect. Fig. 9: Six months postoperative Paul S. Rosen, DMD, MS has a practice limited to periodontics, dental implants and regenerative therapies and is located in Yard- ley, PA. He is a Clinical Associate Professor of Periodontics at the Baltimore College of Dental Surgery at the University of Maryland Dental School in Baltimore, MD and a member of Snoasis Medical's Clinical Advisory Board. He can be reached by phone at (215) 579-0907 or by email at Fig. 10: Six month radiograph References: 1. Chen E, Tofe A. A literature review of the safety and biocompatibility of amnion Tissue . J Imp Clin Adv Dent. 2009; vol 2, No.

8 3: 67-75. Tel: 1-866-521-8247. 2. Park C, Kohanim S, Zhu L et al. Immunosuppressive property of dried human amniotic Membrane . Opthalmic Res 2009; 41: 112-113. 3. Baharvand H, Heidari M, Ebrahimi, et al. Proteomic analysis of epithelium-denuded human amniotic Membrane as a limbal stem cell niche. Mol Vis 2007; 18(13): 1711-1721. BioXclude is a trademark of Snoasis Medical, Inc. 2009. 4. Pakkala T, Virtanen I, Oksanen J, et al. Function of laminins and laminin-binding Manufactured by Surgical Biologics, a MiMedx Group Company. Patents Pending. integrins in gingival epithelial cell adhesion. J Perio 2002; 73(7): 709-719. Redefining Perioplastic Surgery 101006rv02.