Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations
研究概览
简要总结
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:
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Pre-operatively:
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cone beam computed tomography CBCT
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1 minute mouthwash with a 0.12% Chlorhexidine solution
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Full thickness muco-periosteal flap and ridge curettage.
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Drilling and implant placement (any implant system)
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Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
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Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.
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Post-operatively:
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Medication:
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Amoxicilline (1g) or Clindamycine (300mg)
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Analgesic, (paracetamol + codeine)
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Mouthwash with a solution of 0.12% Chlorhexidine
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cone beam computed tomography CBCT
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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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years old
- •Smoking <10 cigarettes/day (Light smoker)
- •Good general health.
- •Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.
排除标准
- •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
结局指标
主要结局
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations
时间窗: 1 year
cbct radiographic measurements
次要结局
- linear measurements of the amount of grafted bone resorption(1 year)
