Ridge Preservation With New Class of Osteoplastic Materials

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tooth Extraction, Atrophy of Edentulous Alveolar Ridge

Intervention / Treatment
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* Device: Octacalcium phosphate
* Device: Bio-Oss
* Device: Tricalcium phosphate


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: Patient who has any known diseases (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation Female patient who are pregnant or lactating or of child bearing potential not using acceptable methods of birth control (hormonal, barriers or abstinence Patient who are on chronic treatment (i.e., two weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine calcium antagonists, cyclosporine, and non-steroidal anti-inflammatory drugs) within one month of baseline visit Patient who knowingly has HIV or Hepatitis Alcoholism or chronically drug abuse causing systemic compromisation Patient who is a heavy smoker (>10/cigarettes per day). Local exclusion criteria Uncontrolled or untreated periodontal disease Patient who has a full mouth plaque level >30 % at the enrolment visit History of local radiation therapy Presence of oral lesions (such as ulceration, malignancy) Persistent intraoral infection Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease Patient presents an acute endodontic lesion in the test tooth or in the neighbouring areas to the experimental procedure (sites with presence of an asymptomatic chronic lesion are eligible)

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octacalcium phosphate<br>Bone augmentation, after tooth extraction, with Octacalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. | Device: Octacalcium phosphate<br>* Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.<br>* Other names: OctoFor;|
| Active Comparator: Bio-Oss<br>Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide | Device: Bio-Oss<br>* Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide<br>|
| Active Comparator: Tricalcium phosphate<br>Bone augmentation, after tooth extraction, with Tricalcium phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide. | Device: Tricalcium phosphate<br>* Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.<br>* Other names: TriCafor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xenograft, tooth, extraction, alveolar socket, socket preservation, ridge preservation, bone graft, tricalcium phosphate, octacalcium phosphate, bio oss