Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Bone Height
研究概览
简要总结
This study will involve placing donor bone into the back of lower jaw then covering with a newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it will be removed. Implants will be placed in the newly formed bone.
The goal of this study is to test how well using a newly designed titanium mesh and bone particles can grow bone in the back of the lower jaw. The investigators are also checking if the newly formed bone will stay around implants that will have been in use for 12 months.
详细描述
Inclusion Criteria
- Patients are at least 18 years old
- At least two adjacent back teeth in the lower jaw are missing
- No medical contraindication to dental surgery
- Inadequate vertical ridge height at edentulous region (less than 10mm)
Exclusion Criteria
- Unstable systemic diseases or conditions that would compromise the healing potential
- Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)
- Patients who are pregnant or expect to get pregnant
- Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical sextant
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients (ASA I or II)
- •Non-smoker or light smokers (< 10 cigarettes per day)
- •Good oral health (FMPS and FMBS <20%)
- •At least two adjacent mandibular posterior teeth are missing
- •Inadequate vertical ridge height at edentulous region (less than 10mm)
- •Missing teeth for ≥ 3 months
排除标准
- •Unstable and complicated systemic diseases or chronic disorders precluding surgical procedures
- •Systemic diseases with compromised healing potentials (Uncontrolled Diabetes Mellitus, HIV infections, etc.)
- •Bone disorders (Hyperparathyroidism, Osteoporosis, Paget's Disease)
- •Pregnant or expecting to become pregnant
- •Currently smoking (≥ 10 cigarettes/day)
- •Poor oral hygiene (≥20% Modified O'Leary Plaque Index)
- •Severe grinding, clenching, TMJ disorder
- •Untreated dental disease (periodontitis, caries, abscesses) in the research quadrant
- •Teeth exhibiting periapical pathology or purulence (symptomatic) in the research quadrant
结局指标
主要结局
Bone Height
时间窗: 5 months
Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
次要结局
未报告次要终点
研究者
Hsun-Liang Chan
Assistant Professor
University of Michigan