Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The purpose of this pilot project is to evaluate the efficacy of application of
      Amnion-Chorion allograft membrane on the root surface of periodontally diseased teeth in
      conjunction with bone substitute covered by Amnion-Chorion allograft in a combination Guided
      Tissue Regeneration (GTR) treatment of periodontal intrabony and furcation defects.
    

Detailed description: 
      Patients who are referred to the Graduate Periodontics Clinic at Indiana University School of
      Dentistry for the treatment of severe chronic/aggressive periodontitis will be screened for
      possible participation in this study. Up to 20 subjects will be accepted into this study.

      Written informed consent and authorization will be obtained from all participants and they
      will be given a copy of the signed informed consent documents.

      The procedures listed below are all within standard care for a regenerative therapy around
      the teeth except the application of the membrane on the root surface prior to the bone
      grafting. No data collected for this study will be taken from sources outside of that already
      recorded for standard of care procedures.

      Clinical Measurements A single calibrated examiner will perform clinical baseline and 6-month
      follow up measurements. O'Leary plaque score will be assessed. Six sites of each tooth of
      probing depth (PD), recession (REC) and clinical attachment level (CAL) will be recorded to
      the nearest millimeter with a University of North Carolina Probe (UNC Probe). For Glickman
      grade II furcation defects, in addition to the previous measurements, vertical probing pocket
      depth (VPD) and horizontal probing depth (HPD) will be measured.

      Radiographic assessment will be performed with vertical bite-wing radiographs at baseline and
      6-month post-surgical treatment. In order to maximize the standardization of the angulation
      of radiographs, bite registration will be taken prior to the first radiograph and utilized
      with beam-guiding device. It will be stored to be used post operatively. Sirona Dental
      Systems© with 7mA 60kV with 0.16s exposure time will be utilized for all radiographs. Digital
      #2 films manufactured by Air Techniques Inc. will be used for radiographic assessment. Bony
      defect (BD) will be defined as the most coronal point where the periodontal ligament space
      showed a continuous width. If several bony contours could be identified, the most apical one
      that crossed the root will be defined as the boney defect and the most coronal one as
      alveolar crest. If the cemento-enamel junction (CEJ) was destroyed by the restorative
      treatment, the margin of the restoration will be taken as a landmark. Beam guided device will
      be used as a calibration of measurements. The change of bone fill and angulation will be
      recorded.

      All surgery will be rendered at the Graduate Periodontics Clinic at Indiana University School
      of Dentistry. All the patients will be treated under local anesthesia (2% lidocaine with
      1/100,000epi or 4% articaine with 1/100,000epi). If the patient is willing to receive the
      surgery under intravenous or oral sedation, those services will be provided based on the
      necessity. After local anesthesia, intracrevicular incisions will be made and full-thickness
      mucoperiosteal flaps will be raised both buccally and lingually; the surgeon will try to
      preserve the maximum extent of the marginal and interdental gingival tissue to obtain primary
      closure and membrane coverage. Vertical releasing incisions will only be used if necessary to
      gain access for defect debridement. The alveolar bone will be exposed at least 3 mm beyond
      the edges of the defect, and periosteal releasing incisions will be made to ensure complete
      membrane coverage at the time of suturing if necessary. All granulation tissue will be
      removed, the defects will be debrided, and the roots will be thoroughly scaled and root
      planed by hand instruments and ultrasonic devices. Following debridement, 17%
      Ethylenediaminetetraacetic acid (EDTA) solution with cotton pellet will be applied on the
      root surface for 2 minutes. After thorough irrigation with saline, BioXclude® (Amnion-Chorion
      Membrane: Food and Drug Administration (FDA) Approved materials for intrabony defects) will
      be cut into two pieces. The amnion-chorion BioXclude membrane is regulated by the FDA under
      section 361 of the Public Health Service Act as a "Human cells, tissues, and cellular or
      tissue-based product" (HCT/P). The FDA does not require pre-market approval for these
      products like it would with drugs, biologics or devices. Therefore, this product will have no
      associated "investigational device exemption" (IDE) number. The FDA views using amnion
      chorion as a wound covering to aid in the healing of tissues throughout the body to be a
      "homologous use". One goes to the root surface, and coronal portion of the membrane has to be
      >3mm coronal of CEJ. Once applied the membrane, one drop of saline will be applied to obtain
      better adaptation of membrane on the root surface. Bone substitutes 0.5cc (Particle size of
      0.25-0.5mm of Corticocancellous, Maxxeus®) will be hydrated for at least 10min prior to
      application, and applied into the defects. The bone particles will not exceed the edge of
      defects in order to avoid over fill. Following the bone graft will be delivered to the
      defect. The coronal portion of excessive membrane will be just folded over the graft
      materials. The other BioXclude membrane will be utilized over the grafts, and will always be
      placed coronal to the interproximal bone crest so that it completely covers the defect and
      extends 2 to 3 mm beyond the residual bone. No sutures, pins, or tacks will be used for
      membrane fixation or stabilization. The orientation of the membrane will not matter. Vertical
      or horizontal mattress sutures with 5-0 Proline (Monofilament/Nylon) will be placed in the
      interproximal tissues to obtain primary closure as much as possible.

      Intra-surgical Clinical Measurements. Intrabony defects: defect morphology will be measured
      (1 wall, 2 walls and/or those combinations) from the deepest aspect of the defect from the
      most coronal side of edge of the defects.

      Furcation defects: 1) Cementoenamel junction to roof of furcation (CEJ-ROF); 2) roof of
      furcation to base of defect (ROF-BOD); 3) roof of furcation to crest of bone at furcation
      entrance (ROF-COB); 4) crest of bone to base of defect (COB-BOD); 5) root divergence at crest
      of bone (RDCB); 6) horizontal extent (base) of defect at level of furcation entrance (HBODF);
      7) horizontal extent (base) of defect at level of crest of bone (HBOD-C); and 8)
      cemento-enamel junction to interproximal crest of bone (CEJ-INTPRX)

      All patients will receive antibiotics (875mg amoxicillin twice /day) for one week. If
      participants are allergic to amoxicillin, clindamycin (150mg twice/day) for one week will be
      prescribed. Analgesics (600mg ibuprofen three times/day) will be prescribed as needed for
      discomfort. Pt will be seen one, two and four weeks as a post-operative follow up. Patients
      will be advised to rinse twice daily with 0.12% chlorhexidine for 2 weeks after surgery.
      Patients will be instructed to refrain from brushing the teeth in the surgical area for 2
      weeks. After that, they will be instructed to initiate brushing with an extra-soft
      toothbrush. Subjects will be recalled at 4-week intervals after 4weeks from surgical
      procedure for a period of 6 months for plaque scoring, oral hygiene instruction, and
      professional prophylaxis as needed. No subgingival probing or instrumentation will be
      performed at the experimental sites until the 6-month follow-up appointment.
    

Intervention name(s): Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.
Intervention type(s): Procedure
Intervention description(s): Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
Intervention model: Single Group Assignment
Intervention model description: Prospective Case Series
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Guided Tissue Regeneration,; Amnion-Chorion,; Intrabony defects,; furcation