NCT02155764

Ridge Preservation With New Class of Osteoplastic Materials

Comparison of Octacalcium Phosphate Synthetic Bone Graft (OctoFor) and Bovine-derived Bone (Bio-Oss) for Ridge Preservation After Tooth Extraction: Open, Prospective, Non-Randomised Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 17 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-01
• Completion: 2019-04-01
• First posted: 2014-06-04
• Last updated: 2019-04-22

Locations

1 site across 1 country: Russia