Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration

Study Overview
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Brief Summary
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to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study: Pre-operatively: cone beam computed tomography CBCT 1 minute mouthwash with a 0.12% Chlorhexidine solution Full thickness muco-periosteal flap and ridge curettage. Drilling and implant placement (any implant system) Adjustment and placement of the Bio-Oss Collagen in the regeneration site without a fixation membrane. Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material. Post-operatively: Medication: Amoxicilline (1g) or Clindamycine (300mg) Analgesic, (paracetamol + codeine) Mouthwash with a solution of 0.12% Chlorhexidine cone beam computed tomography CBCT 4 months postoperatively: CBCT Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique

Official Title
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Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study

Conditions
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Bone Regeneration

Intervention / Treatment
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* Procedure: bone regeneration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old Smoking <10 cigarettes/day (Light smoker) Good general health. Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding. Exclusion Criteria: A pregnant or nursing mother Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy. Orthodontic treatment in progress or planned - Adjacent risk teeth

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bio-oss Collagen<br>90% xengeneic bovine bone partciles + 10% collagen type I | Procedure: bone regeneration<br>* bone regeneration using bio-oss collagen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations | cbct radiographic measurements | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| linear measurements of the amount of grafted bone resorption | cbct radiographic measurements | 1 year |