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Edentulous Alveolar Ridge clinical trials

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NCT ID: NCT01929954 Terminated - Clinical trials for Edentulous Alveolar Ridge

Safety Study of Gintuitâ„¢ in Subjects Requiring Socket Grafting

Start date: July 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).

NCT ID: NCT01800149 Completed - Clinical trials for Edentulous Alveolar Ridge

Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT

Start date: February 2013
Phase: Phase 4
Study type: Interventional

Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study. After tooth extraction, sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules). The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured. MEASUREMENTS: The end of the study will be fixed at the 6 months evaluation after tooth extraction. Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal dimension of the soft tissues will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months). A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition will be performed in order to measure hard tissue remodelling. After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned.