NCT06636084
撤回
不适用
Vertical and Horizontal Mandibular Ridge Augmentation Techniques: A Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Vertical Ridge Deficiency
- 发起方
- University of Michigan
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Ridge width changes in mm
- 状态
- 撤回
- 最后更新
- 9个月前
概览
简要总结
The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan
入排标准
入选标准
- •Age ≥ 18 years
- •Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- •Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects \>≥3mm.
- •Capacity to understand and accept the written conditions of the study.
排除标准
- •Insufficient oral hygiene.
- •Smoking habit of \>10 cigarettes/day (self-reported).
- •Abuse of alcohol or drugs.
- •Pregnancy or individuals attempting to get pregnant (self-reported).
- •Acute local or systemic infections.
- •Uncontrolled diabetes or other metabolic disease.
- •Severe hepatic or renal dysfunction.
- •Autoimmune disorders.
- •Patients who underwent radiotherapy in the last 5 years.
- •Patients undergoing immunosuppressive therapy or who are immunocompromised.
结局指标
主要结局
Ridge width changes in mm
时间窗: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Ridge height changes in mm
时间窗: 6 months
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
次要结局
- Change in the mucosal thickness in mm(6 months)
- Histological outcomes of the augmented bone(6 months)
- The volumetric bone gain of the grafted area in mm3(6 months)
- Rate of complications(6 months)
- Cost analysis(6 months)
研究点 (1)
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