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Periodontal Regeneration of 1-, 2-, and 3-Walled Intrabony Defects Using Accell Connexus Versus Demineralized Freeze-Dried Bone Allograft: A Randomized Parallel Arm Clinical Control Trial
Uniformed Services University Of The Health Sciences Bethesda United States
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Introduction This thesis discusses the research project undertaken to determine if Accell connexus, a demineralized freeze-dried bone allograft product that contains 5-7 times the amount of bone morphogenetic proteins as regular demineralized freeze-dried bone allograft DFDBA provides superior periodontal regeneration formation of new bone, cementum, and connective tissue around teeth than regular demineralized freeze-dried bone allograft. Methods and Materials Thirty patients diagnosed with servere periodontitis, having at least on intrabony defect with a probing depth -6 mm, will be enrolled. Participants will have impressions made of their upper and lower teeth to provide dental stone models of the maxillary and mandibular arches. Customized plastic stents fabricated on the models will be used by blinded investigators to obtain standardized clinical measurements of the defects before surgery and at 6 and 12 months after surgery. Measurements will include probing depths and clinical attachment levels. Standardized digital radiographs using a customized bite-plate and a paralleling technique for reproducibility will be used to take periapical radiographs at baseline and 6 months and 12 months after surgery. All participants will receive the same standardized surgical approach. Whether surgery is performed with local anesthesia only, or under local anesthesia and sedation, will be a choice made between the surgeon and the patient. During surgery, the depth and width of the intrabony defect will measured after the defect is debrided. Study investigators not the participants surgeon blinded to the bone graft material a participant receives will make all clinical measurements and take radiographs for the study.
APPROVED FOR PUBLIC RELEASE