NCT05593198已完成不适用
Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bone volume
研究概览
简要总结
The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in need of an implant-supported rehabilitation
- •Patients requiring bone regeneration
- •Healthy patients
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
- •Sufficient mesiodistal and interocclusal space
- •At least 6 months of follow-up
排除标准
- •An American Society of Anesthesiologists physical status classification ≥ III
- •General contraindications for surgical treatment or implant placement
- •Untreated periodontitis
- •Excessive alcohol consumption
- •Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
- •No residual keratinized tissue at the experimental area
- •Unwillingness to return for follow-up examinations
结局指标
主要结局
Bone volume
时间窗: 6 Months follow up
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
次要结局
- Periodontal parameters(6 Months follow up)
- Histological analysis(6 Months follow up)
- Wound healing(2 weeks follow up)
研究者
研究点 (1)
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