One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in bone density buccal to the implant
研究概览
简要总结
Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.
The participants were randomly allocated using a computer system into two groups:
Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.
Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.
Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (20-45) years of age with no sex predilection
- •At least one tooth missing in the anterior maxilla
- •The presence of a labial undercut >2 mm in thickness which is not able to house an implant
- •The presence of adequate bone width near the alveolar bone crest
- •The absence of a vertical bone defect.
排除标准
- •History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
- •Pregnancy or lactation.
- •Long-term amino-bisphosphonate therapy.
- •Smoking more than 10 cigarettes per day.
- •Alcohol or drug abuse.
- •Uncontrolled periodontal disease.
- •Active infection.
- •Inadequate inter-incisal space.
- •Bruxism or clenching.
研究组 & 干预措施
Two-stage ridge splitting
干预措施: Two-stage ridge splitting with implant placement (Procedure)
One stage ridge splitting
干预措施: One stage ridge splitting with simultaneous implant placement (Procedure)
结局指标
主要结局
Change in bone density buccal to the implant
时间窗: baseline and 4 months
Bone density was evaluated by CBCT
Change in bone width gain at the undercut area
时间窗: baseline and 4 months
Bone width gain was evaluated by CBCT
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University