Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical alveolar ridge dimension changes
研究概览
简要总结
This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.
详细描述
Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.
30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 20 to 80 years.
- •Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
- •Socket should be free of infection, less than 5mm of dehiscence
- •Patients interested in implant placement following tooth extraction.
排除标准
- •Allergies or hypersensitivities to study related medications such as chlorhexidine.
- •Hematologic disorders/blood dyscrasias.
- •Active infectious diseases of any kind.
- •Liver or kidney dysfunction/failure.
- •Uncontrolled diabetes (HbA1c > 8).
- •Active cancer treatment - such as active chemotherapy or radiation therapy.
- •Taking medications that will affect their bone healing (for example, bisphosphonates).
- •Metabolic bone diseases that affect bone healing such as osteoporosis.
- •Pregnant or lactating women (self-reported).
- •Smoke 10 or more cigarettes per day (self-reported).
- •Poor oral hygiene.
结局指标
主要结局
Clinical alveolar ridge dimension changes
时间窗: 4 months
Clinically measured alveolar ridge dimension changes in mm using calibers
Digital alveolar ridge dimension changes
时间窗: 4 months
Digitally measured alveolar ridge dimension changes in mm2 using CBCT
次要结局
- Histological bone density.(4 months)
- Esthetic restorative outcomes.(6 months)
- Implant survival-Radiographic(6 months)
- Implant survival-Clinical(6 months)
- Presence of bone turnover proteins.(4 months)
研究者
Muhammad Saleh
Clinical Assistant Professor, Periodontics and Oral Medicine
University of Michigan