Bone Remodeling After Immediate Implant Placement With and Without Bone Grafting

The purpose of the current study is to evaluate the soft tissue dimensional changes after
extraction of teeth in the esthetic zone, when combined with the placement of implants into
these fresh extraction sockets. In addition, the effect of placing a graft material, such as
Bio-Oss Collagen® into the gap between implant and the labial plate of bone will be evaluated
after an immediately loaded provisional restoration is placed. 32 subjects will have an
immediate dental implant placed in the maxillary anterior region (#4-12) after extraction of
a hopeless tooth. 16 subjects will be randomly selected to receive Bio-Oss Collagen® (Test
group) and 16 subjects will have no graft (Control group) in the gap between the implant and
the labial plate of bone. Hopeless maxillary anterior teeth will be extracted and implants
will be placed in a flapless procedure. Implants will be immediately loaded with provisional
restorations once determined that the implant is stable. Changes in vertical height and
horizontal dimensional changes of the free gingival margins will be evaluated at 3, 6, and 12
months post-immediate implant placement.

Inclusion Criteria:

1. Subject must have read, understood and signed an informed consent form.

2. Subjects must be willing and able to follow study procedures and instructions.

3. Subjects must have labial plate of bone present after extraction no more than 4 mm
from the free gingival margin.

4. Subjects must require one maxillary anterior implant.

5. Subjects must be older than 18 years

Exclusion Criteria:

1. Subjects having participated within the last six months in other clinical studies.

2. Subjects who have failed to maintain good plaque control.

3. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer,
human immunodeficiency virus (HIV), disorders that compromise wound healing, chronic
high dose steroid therapy, bone metabolic diseases, radiation or other
immuno-suppressive therapy which would preclude periodontal surgery.

4. Subjects with the presence of acute infectious lesions in the areas intended for
surgery.

5. History within the last 6 months of weekly or more frequent use of smokeless chewing
tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per
day).

6. Female subjects who are pregnant or lactating, or who intend to become pregnant during
the study period following entrance into the study.

7. Subjects on Bisphosphonate Therapy with C-terminal telopeptide (CTX) values <100

8. Subjects requiring antibiotic prophylaxis for subacute bacterial endocarditis (SBE) or
late prosthetic joint infection. Patients who cannot undergo standard oral surgery
procedure for any reason.

9. Subjects that have adjacent teeth next to tooth slated for extraction and immediate
placement showing periodontal disease, endodontic and/or caries pathology will be
excluded.

10. Subjects having unfavorable occlusal schemes for immediate loading, parafunctional
habits and inadequate posterior support to properly protect the anterior teeth during
function.

11. Implant site will not be next to an adjacent implant.