Tooth Extraction, Atrophy of Edentulous Alveolar Ridge
Conditions
Keywords
tooth, extraction, alveolar socket, socket preservation, ridge preservation, bone graft, tricalcium phosphate, octacalcium phosphate, xenograft, bio oss
Brief 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.
Interventions
DEVICEOctacalcium phosphate
Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
DEVICEBio-Oss
Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
DEVICETricalcium phosphate
Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
Sponsors
Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia
Bionova, Skolkovo Community, Russia
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient must have voluntarily signed the informed consent * Males and females, 18 years to 75 years of age * Patient needs single tooth extraction in mandibular or maxillary incisor or pre-molar region and would benefit from prosthetic reconstruction with a dental implant * Patients must be committed to the study and must sign informed consent * Patient in good general health as documented by self assessment
Exclusion criteria
Systemic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of bone level between baseline and 3 months post-extraction at the time of implantation | baseline and 3 months post-extraction | A prefabricated stent will be used as an anchor point. After tooth extraction size of dehiscence of buccal bone from anchor point to the alveolar crest will be measured (baseline). Socket will be filled with biomaterial. After 3 months of healing at the time of implant placement the same stent will be used as an anchor point to measure size of dehiscence after socket preservation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent new vital bone formation | 3 month | Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent residual graft material and percent connective tissue | 3 month | Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue |
Countries
Russia
Outcome results
None listed