Ridge Preservation With New Class of Osteoplastic Materials
NCT02155764 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-04-22
Summary
Return to normal life and shortening rehabilitation period of patients after surgical removal of teeth is important and urgent social problem. In this regard, higher demands for quality of care and treatment of patients, which requires the development of new approaches to the treatment of patients, the introduction of new technologies and the associated development of new materials . Serious problem of contemporary oral and maxillo-facial surgery and dentistry is augmentation of bone defects generated during the surgical treatment of diseases and injuries of the bones. The results of surgical repair of bone defects are more dependent on the course of the process of reparative osteogenesis. Long-term periods of clinical studies indicate that reparative osteogenesis in posttraumatic bone defects is slow - months and years, and in some cases no bone defects filled with bone tissue.
This project aims at addressing the preservation of bone volume in humans after tooth extraction using biomaterials with optimum performance. The practical significance of the project is to establish an effective tissue response and, thus, possible subsequent quality installation of dental implants. The proposed solution is based on the scientific development of the operative techniques, and a comparative analysis of several classes of biomaterials (xenogenic and synthetic analogs), including the use of biological precursors of bone apatite mineralization having osteoinductive (stimulating) properties.
Conditions
- Tooth Extraction
- Atrophy of Edentulous Alveolar Ridge
Interventions
- DEVICE
-
Octacalcium phosphate
Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
- DEVICE
-
Bio-Oss
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
- DEVICE
-
Tricalcium phosphate
Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Sponsors & Collaborators
-
Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia
collaborator UNKNOWN -
Bionova, Skolkovo Community, Russia
collaborator UNKNOWN -
I.M. Sechenov First Moscow State Medical University
lead OTHER
Principal Investigators
-
Anatoly Kulakov, Prof · Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 17 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-09-01
- Primary Completion
- 2018-12-01
- Completion
- 2019-04-01
Countries
- Russia
Study Locations
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