Guided Island Osteoperiosteal Flap Versus Ridge Splitting for Anterior Atrophic Maxillary Augmentation With Implant Placement (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in bone density
研究概览
简要总结
Background: After tooth extraction changes of the shape of the alveolar bone follows a predictable pattern, which proves to be challenging in restoring its form and function, especially in the esthetic zone. Autogenous grafts remain the gold standard because of their predictability. The island osteoperiosteal flap (I-flap) is introduced as a modified alveolar split bone grafting technique used to gain width, height and modify the facial or buccal bone plate position.
Aim of the study: This study aims to evaluate in anterior atrophic maxillary ridge augmentation using guided unreflected island osteoperiosteal flap (I-Flap) approach with simultaneous implant placement and interpostional bone grafting in comparison to computer guided ridge splitting method.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient seeking replacement of a missed maxillary anterior tooth by a delayed dental implant procedure.
- •Residual bone height is (8-15) mm and (3-4) mm alveolar bone width.
- •Good oral hygiene.
排除标准
- •Uncontrolled Diabetes.
- •Coagulation disorders.
- •Immunological disorders.
- •Previous radiation of the head and neck region.
- •Abnormal bone physiology.
- •Therapy with Bisphosphonates.
- •Heavy smokers.
研究组 & 干预措施
Computer guided conventional ridge splitting
干预措施: Conventional ridge splitting (Procedure)
Computer guided island flap
干预措施: Island osteoperiosteal flap (Procedure)
结局指标
主要结局
Change in bone density
时间窗: baseline and 4 months
Bone density at implant body is measured by using computerized tomography values
Change in pain scores
时间窗: 1 day, 3rd day and 1 week
Pain (by Visual Analogous Scale): Score 0 - No pain. Scores 1 to 3 - Mild pain. Scores 3 to 7 - Moderate pain. scores 7 to 10 - severe pain.
Secondary implant stability
时间窗: 4 months
implant stability was measured using ostell device
Change in bone level (bone gain)
时间窗: Baseline and 4 months
Immediate post-operative CBCT (T1) will be done to measure the alveolar bone gain, to assess the proper implant positioning, and finally to measure the width of the out-fractured buccal plate and the amount of interpositional bone graft. Four months postoperatively CBCT (T2) will be done to measure amount of bone gain
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University