Clinical trial NCT02952209: The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla
Official title: The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla: A Randomized, Split-Mouth, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Extraction
Keywords: Alveolar Ridge Preservation
Xenograft bone graft
Collagen membrane
Lead sponsor: NYU College of Dentistry
Sponsor class: OTHER
Collaborators: name: Osteo Science Foundation
First posted: 2016-11-02
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the bucco-palatal width of the alveolar ridge measured in mm.
timeFrame: 6 Months
measure: Changes in the vertical height of the alveolar ridge measured in mm.
timeFrame: 6 Months
Secondary outcomes:
measure: Alveolar bone volumetric changes measured in mm.
timeFrame: 6 Months
measure: Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm.
timeFrame: 6 months
measure: Bone density changes from measured in mm.
timeFrame: 6 Months
measure: Changes in keratinized mucosa width and thickness measured in mm.
timeFrame: 6 months
measure: Correlation of soft tissue and buccal bone wall thickness measured in mm.
timeFrame: 6 months
measure: Subject satisfaction will be assessed through questionnaire.
timeFrame: 6 Months
measure: Need for additional bone augmentation, including sinus bone augmentation measured in mm.
timeFrame: 1.5 Years
measure: Implant success rate measured by percentage.
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bluestone Center for Clinical Research
state: New York
Study officials:
affiliation: Bluestone Center for Clinical Research
name: Ismael E. Khouly, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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