Biologically Oriented Alveolar Ridge Preservation with Layered Collagen and Xenograft (A Randomized Controlled Clinical Trial with Histological Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Measuring the clinical alveolar ridge changes
研究概览
简要总结
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone. Measuring the clinical and radiographic alveolar ridge dimensional changes following after preservation at the time of implant placement
详细描述
alveolar ridge preservation using deep collagen layer, xenograft and collagen membrane seal versus the use of xenograft and collagen membrane seal alone.
The primary objective of the study is measuring the clinical and radiographic alveolar ridge dimensional changes following the procedure 4 months post operatively
The secondary objective :
- Histological assessment of alveolar bone specimens to assess bone remodeling and new bone formation in both studied groups after four months.
- Patient satisfaction after implant placement
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
- Single (Outcomes Assessor)
盲法说明
the outcome assessor will be blinded about the grouping and which patient got which treatment
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients (American Society of Anesthesiologists I; ASA I).
- •Patients diagnosed with single unrestorable molar teeth (socket type I) requiring extraction and implant placement (Elian et al.2007).
- •Teeth free from any infection or periapical pathosis.
- •Enough zone of keratinized tissue with at least 2mm.
- •Good compliance with the plaque control instructions following initial therapy.
- •Availability for follow up and maintenance program.
排除标准
- •Bad oral hygiene.
- •Presence of smoking habit.
- •Presence of occlusal interferences
- •Pregnant females
- •Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).
结局指标
主要结局
Measuring the clinical alveolar ridge changes
时间窗: at baseline and 4 months
Measuring the thickness of the alveolar ridge in mm
Measuring the radiographic change in the buccal bone thickness
时间窗: at baseline and 4 months
Measuring the change in the thickness of the buccal ridge radiographically in mm
Measuring the radiographic alveolar ridge dimensional changes
时间窗: at baseline and 4 months
Measuring the bone density in hounsfield units (HU)
次要结局
- Histological assessment of core biopsy(4 months post operatively)