Amnion-Chorion Allograft Barrier Used for Root Surface and Guided Tissue Regeneration for Periodontal Intrabony Defects and Grade II Furcation Defects.

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 BD 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% EDTA solution
with cotton pellet will be applied on the root surface for 2 minutes. After thorough
irrigation with saline, BioXclude® (Amnion-Chorion Membrane: 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.

Inclusion Criteria:

1. ASA class I or II;

2. age >18 years old;

3. Non-smoker;

4. diagnosis of chronic or aggressive periodontitis previously treated with nonsurgical
mechanical debridement; 5) patients have at least one two-wall intrabony defect in
interproximal areas with radiographic evidence of an intrabony component of ≥ 4 mm,
PPD ≥ 6 mm with 1-wall or 2-wall or combination of those defects;

6) Glickman Grade II furcation involvement on buccal of mandibular or maxillary first or
second molars without soft tissue exposure of furcation entrance; 7) tooth mobility Miller
Grade <1; 8) more than 2mm of keratinized tissue with those selected teeth.

Exclusion Criteria:

1. did not meet all inclusion criteria;

2. pregnancy or nursing woman;

3. subjects with active systemic or localized infection (exclude chronic periodontitis);

4. poor compliance or failure to maintain good oral hygiene as ascertained by the
presence of full-mouth plaque score ≥ 20%;

5. restorations or caries on root surfaces or untreated endodontic infections;

6. participants received periodontal surgical treatment on the same site of this study
within 2 years;

7. use of systemic or local antibiotics on the anticipated surgical sites during the past
3 months.