The "Open Wound Bone Augmentation Concept" With Amnion-Chorion Membrane: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Ridge width changes
研究概览
简要总结
The purpose of this study is to compare two bone graft wound healing techniques; an open wound healing approach versus the standard closed wound healing approach.
详细描述
Open wound healing approach (experimental technique): the wound where the graft was attached to the bone will be filled with a type of tissue (the amnion-chorion membrane) taken from a placenta (the tissue sac that surrounds an embryo) and will be left partially open to heal.
Closed wound healing approach (standard technique): the wound where the graft was attached to the bone will be filled with collagen tissue (processed bone grafts from donors) and stitched closed while it heals.
20 patients needing more bone before placing a dental implant will be recruited for this trial. Patients will be randomized to either the test (open wound healing approach) or control (closed wound healing approach) group.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 21 years of age
- •Be missing 1 to 2 back teeth in the lower jaw for at least three months
- •Need horizontal bone ridge augmentation (gain width of the bone) prior to implant placement, determined clinically and radiographically
- •Have enough bone height at the site
排除标准
- •Currently smoke more than 10 cigarettes a day (self-reported)
- •Have any medical conditions or jaw pathology that we decide might influence the outcome of the study
- •Are pregnant or are lactating (self-reported)
- •Have unstable periodontal disease or other dental infection
- •Have poor oral hygiene
- •Have any clinical conditions that make the subject unsuitable for bone graft surgery
结局指标
主要结局
Ridge width changes
时间窗: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
次要结局
未报告次要终点
研究者
Muhammad Saleh
Clinical Assistant Professor
University of Michigan