Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft

The study is designed to examine histologic wound healing following ridge preservation using
cortical bone allograft, cancellous bone allograft, or a combination of both cortical and
cancellous bone allograft. This entire protocol involves procedures that are standard care.
All materials are FDA-approved materials being used in an FDA-approved manner. The study is
a 3-arm, parallel-design, randomized, prospective clinical trial. The test group subjects
will have extraction sockets grafted with a combination of 50% cortical/50% cancellous FDBA.
This test group will be compared to two active control groups - one using 100% cortical FDBA
and the other using 100% cancellous FDBA. The null hypothesis is that there will be no
significant difference in formation of new vital bone between treatment groups (primary
outcome).

Each subject will provide a single non-molar tooth site for study treatment. After tooth
extraction, the graft material will be placed and covered by a non-resorbable membrane.
Following 18-20 weeks of healing, the dental implant will be place, at which time a core of
bone will be removed from the site as part of the preparation for the implant. The core
biopsy will then be evaluated for the primary histologic outcome of % vital bone formation
and secondary histologic outcome of % residual graft material.

Inclusion Criteria: Patients will be included in this study if they qualify the following
inclusion criteria:

- Live within 50 miles from the School of Dentistry, University of Texas Health Science
Center at San Antonio

- Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the
study protocol

- A single rooted tooth that has been identified as requiring extraction

- Desire a dental implant to replace the missing tooth

- Have adequate restorative space for a dental implant-retained restoration

- Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus
or inferior alveolar canal.

- Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending
no more than 50% of the total depth of the socket.

- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and
non-pregnant women of child-bearing potential.

- Are nonsmokers or former smokers. Current smokers may only be included if they smoke
<10 cigarettes per day

Exclusion Criteria:

- Patients who live more than 50 miles from the School of Dentistry, University of
Texas Health Science Center at San Antonio

- Patients who do not meet all the inclusion criteria or who will not cooperate with
the required follow-up schedule.

- Patients will are mentally incompetent, prisoners, or pregnant.

- Pregnant women or women intending to become pregnant during the study period.

- Smokers who smoke >10 cigarettes per day

- Clinical and/or radiographic determinations which will preclude inclusion in this
study are: Active infection other than periodontitis; Inadequate bone dimensions or
restorative space for a dental implant; Presence of a disease entity, condition or
therapeutic regimen which decreases probability of soft tissue and bony healing,
e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents,
autoimmune diseases, history of bisphosphonate use or long-term steroid therapy;
Positive medical history of endocarditis following oral or dental surgery.

- Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or
surfactants