Vertical and Horizontal Mandibular Ridge Augmentation Techniques: A Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Ridge width changes in mm
研究概览
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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.
- •Any other contraindications for undergoing surgery.
研究组 & 干预措施
Customized CAD/CAM Titanium Mesh
A customized CAD/CAM Titanium Mesh will be used to cover the bone graft
干预措施: Guided bone regeneration (GBR) (Procedure)
Reinforced Perforated PTFE Mesh (RPM)
A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft
干预措施: Guided bone regeneration (GBR) (Procedure)
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)
研究者
Hom-Lay Wang, DDS, MSD, Ph D
Collegiate Professor of Periodontics and Professor of Dentistry
University of Michigan