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| ID | Type | Description | Link |
|---|---|---|---|
| 11-13 | Other Identifier | The I.M. Sechenov Moscow Medical Academy |
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| Name | Class |
|---|---|
| Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery, Moscow, Russia | UNKNOWN |
| Bionova, Skolkovo Community, Russia | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octacalcium phosphate | Experimental | Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
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| Bio-Oss | Active Comparator | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide |
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| Tricalcium phosphate | Active Comparator | Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octacalcium phosphate | Device | Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of bone level between baseline and 3 months post-extraction at the time of implantation | 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. | baseline and 3 months post-extraction |
| Measure | Description | Time Frame |
|---|---|---|
| Percent new vital bone formation | Bone core biopsy will be evaluated histologically for percent new vital bone formation at the time of implantation | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percent residual graft material and percent connective tissue | Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue | 3 month |
Inclusion Criteria:
Exclusion Criteria:
Systemic exclusion criteria:
Local exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anatoly Kulakov, Prof | Central Scientific Research Institute of Dentistry and Maxillo-facial Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cental Scientific Research Institute of Dentistry and Maxillo-facial Surgery | Moscow | RU | 119991 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23268211 | Background | Gurin AN, Komlev VS, Fadeeva IV, Petrakiva NV, Varda NS. [A comparative study of bone regeneration potency of alfa and beta-tricalcium phosphate bone substitute materials]. Stomatologiia (Mosk). 2012;91(6):16-21. Russian. | |
| 22332385 | Background | Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Calcium phosphate bone cements. Application in oral and maxillofacial surgery]. Stomatologiia (Mosk). 2011;90(5):64-72. No abstract available. Russian. |
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| Bio-Oss | Device | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide |
|
| Tricalcium phosphate | Device | Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. |
|
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| 21186653 | Background | Gurin AN, Komlev VS, Fadeeva IV, Barinov SM. [Octacalcium phosphate--precursor of biomineralization, novel bone scaffold]. Stomatologiia (Mosk). 2010;89(4):57-64. Russian. |