The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla



Status:Recruiting
Healthy:No
Age Range:20 - 90
Updated:8/30/2018
Start Date:October 2016
End Date:November 2019
Contact:Ismael E. Khouly, DDS, MS, PhD
Email:IEK3@nyu.edu
Phone:212-998-9453

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The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.

This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth
extraction compared to extraction alone in the posterior maxilla. The results of this study
will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post
extraction in the posterior maxilla region.

Fifteen subjects requiring extraction of one posterior tooth in the right maxilla and one
posterior tooth in the left maxilla will be considered for enrollment. Subjects who meet the
inclusion and exclusion criteria will be randomized to receive alveolar ridge preservation on
one side of the maxilla and only an extraction on the other side of the maxilla.

Extraction of the failing teeth will be performed atraumatically; a mucoperiosteal flap will
not be employed. After removal of the tooth, the alveolus will be meticulously debrided and
cleaned. In the test site, the socket will be filled with xenograft and a collagen membrane.
In the control site, no graft material or collagen membrane will be used. Clinical
measurements, standardized peri-apical radiographs and Cone Beam Computed Tomography scans
will be performed immediately following tooth extractions (visit 2) and 6 months (visit 4)
after extractions.

Subjects will be examined over the course of 6 months. Investigators will be trained prior to
participating in the study. Training will be undertaken during a site initiation visit and
will include a detailed description of all study procedures including treatment methods, and
measurement methods to obtain study endpoints.

Inclusion Criteria:

1. Subjects must voluntarily sign the informed consent form.

2. Subjects must be male or female who are at least 20-70 years of age.

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

4. Presence of one posterior tooth in the right maxilla and one posterior tooth in the
left maxilla that require extraction (ADA tooth positions 2-4 and 13-15). The same
type of tooth should be in booth side, either two molars or two premolars.

5. Teeth extractions of one posterior tooth in the right maxilla and one posterior tooth
in the left maxilla must be completed successfully (ADA tooth positions 2-4 and
13-15).

6. If present, teeth adjacent to the teeth slated for extraction must be healthy. Healthy
teeth are defined as asymptomatic teeth without periapical lesions.

Exclusion Criteria:

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

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

3. Subjects with any systemic condition such as uncontrolled diabetes mellitus, cancer,
HIV, disorders that compromise wound healing, chronic high dose steroid therapy,
intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of
irradiation of the head and neck area, or any other immuno-suppressive therapy that
would contraindicate oral surgical treatment.

4. Subjects who report allergy or hypersensitivity to any of the products (collagen
membrane and ABBM) used throughout the study.

5. Presence of ≥3 mm of vertical loss of the buccal bone in relation to the palatal wall.

6. Subjects with untreated periodontitis.

7. Presence of acute dentoalveolar infections in the teeth slated for extraction.

8. Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day)
or chew tobacco, including within 3 months prior to enrollment.

9. Subjects with conditions or circumstances, in the opinion of the investigator, which
would prevent completion of study participation or interfere with analysis of study
results, such as history of non- compliance or unreliability
We found this trial at
1
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New York, New York 10010
Phone: 212-998-9456
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