Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Samer Faraj
- 入组人数
- 43
- 主要终点
- Alveolar Ridge Dimensional Changes
研究概览
简要总结
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
详细描述
Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients included in the study were required:
- •Not to be completely edentulous.
- •To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned
排除标准
- •Patients were excluded if they :
- •Had received radiation therapy
- •Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
- •Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
- •Were smokers (more than 10 cigarettes per day)
- •Were pregnant or breastfeeding.
研究组 & 干预措施
Dehydrated Human Amnion Chorion Membrane
This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
干预措施: Guided Bone Regeneration (GBR) (Procedure)
Type I Bovine Collagen Membrane
This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement.
干预措施: Guided Bone Regeneration (GBR) (Procedure)
结局指标
主要结局
Alveolar Ridge Dimensional Changes
时间窗: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Alveolar Ridge Bone Vitality
时间窗: Mean= 19.5 weeks after tooth extraction and bone grafting
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
次要结局
- Ridge Healing Evaluation(Two weeks form the time of the extraction)
研究者
Samer Faraj
Principal Investigator
University of Kentucky