NCT01154868撤回4 期
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation
William Giannobile2 个研究点 分布在 1 个国家开始时间: 2010年8月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- horizontal (width) bone gain or loss in millimeters.
研究概览
简要总结
The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21 and older
- •2-4 ADJACENT maxillary front teeth missing
- •require ridge augmentation and dental implant
- •nonsmoker for at least 6 months
- •willing to follow oral hygiene instruction and other study instruction
- •able to read, understand and sign informed consent
排除标准
- •Residual upper jaw bone equal to or narrower than 3mm.
- •Insufficient gum tissue to obtain wound closure after surgery.
- •Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- •A history of head & neck radiation treatment due to certain medical conditions.
- •Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for >7 days or any investigational drug
- •Pregnancy or become pregnant during the length of the study
- •Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.
结局指标
主要结局
horizontal (width) bone gain or loss in millimeters.
时间窗: 18 weeks
次要结局
- radiographic bone changes measured using computer tomography(18 weeks)
- percentage of new bone formation in the alveolar bone core biopsies.(18 weeks)
研究者
William Giannobile
William Giannobile, D.D.S., D.Med.Sc.
University of Michigan
研究点 (2)
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