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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Bluestone Center for Clinical Research
New York, New York, United States
Changes in the bucco-palatal width of the alveolar ridge measured in mm.
Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data.
Time frame: 6 Months
Changes in the vertical height of the alveolar ridge measured in mm.
Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs.
Time frame: 6 Months
Alveolar bone volumetric changes measured in mm.
Alveolar bone volumetric changes measured using CBCT data and from dental impressions.
Time frame: 6 Months
Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm.
Changes in the distance from the alveolar crestal bone to the sinus floor using CBCT data and standardized periapical radiographs.
Time frame: 6 months
Bone density changes from measured in mm.
Bone density changes measured using CBCT data.
Time frame: 6 Months
Changes in keratinized mucosa width and thickness measured in mm.
Changes in keratinized mucosa width and thickness.
Time frame: 6 months
Correlation of soft tissue and buccal bone wall thickness measured in mm.
Correlation of soft tissue and buccal bone wall thickness on radiographic outcomes.
Time frame: 6 months
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Subject satisfaction will be assessed through questionnaire.
Subject satisfaction will be assessed using a Visual Analogue Scale (VAS) (scored from 0-100) after extraction (visit 2), at 2 weeks (visit 3) and 6 months (visit 4) following tooth extractions.
Time frame: 6 Months
Need for additional bone augmentation, including sinus bone augmentation measured in mm.
Need for additional bone augmentation, including sinus bone augmentation, prior to implant placement at 6 months post extractions
Time frame: 1.5 Years
Implant success rate measured by percentage.
Evaluate dental implant success, in case the subject receives dental implant following healing of alveolar ridge after teeth extractions
Time frame: 6 Months