Extraction Site Preservation Using FDBA With Bioxclude vs. FDBA With Bio-Gide: A Randomized Clinical Trial
Uniformed Services University Of The Health Sciences Bethesda United States
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This randomized, controlled, blinded, clinical investigation will compare extraction site preservation performed with freeze dried bone allograft FDBA and either the Bio-Gide membrane or the BioXclude membrane. Alveolar ridge dimensional changes from the time of extraction until implant placement at 6 months will be assessed. Up to 70 patients treatment planned for an extraction with site preservation and implant placement will be enrolled. Participants will be randomized to receive Bio-Gide or BioXclude. Each participant will have a jaw impression made of the extraction site to provide a stone model for the fabrication of a customized acrylic stent. The stent will be used by blinded investigators to obtain standardized clinical measurements of the alveolar ridge at 6 points around the extraction site, immediately after the extraction, and at 6 months right before implant placement. In addition to the pre-extraction impression, impressions will also be taken at 4 and 12 weeks post-extraction, and at the time of implant placement. The four sets of models from these impressions will be used to measure dimensional changes in the alveolar ridge. Soft tissue closure across the membranes will also be assessed. Study investigators, blinded to the membrane material, will make all clinical measurements. Standard clinical procedure evaluates postoperative healing at 1, 2, 4, 6, 8, 12 and 16 weeks and again at 6 months. For study participants, impressions and research measurements will be made only during these post-operative visits. Data analysis will compare changes in site dimension and soft tissue closure.