Phase 3 Study of Using Combination of Bi Phasic Calcium Phosphate and Bu Phasic Calcium Sulphate During Extractions
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 主要终点
- The change of the dimension of the alveolar ridge
研究概览
简要总结
The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.
详细描述
Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over age
- •Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).
排除标准
- •Inability to pass informed consent procedure
- •Pregnant women
- •Breastfeeding women
- •Patient taking medications that affect bone metabolism such as bisphosphonates
- •Extractions sites contaminated
- •Smoking over 10 cigarettes a day
- •Patients with removable prostheses
结局指标
主要结局
The change of the dimension of the alveolar ridge
时间窗: Immediatly after tooth extraction (up to 10 minutes after the extraction) and 4 monthes after extraction
Measurement of socket width (aspect B/L) at three points Height: 1. Record-high ridge (buccal/lingual-palatal ) 2. 3 mm apically to the peak ridge (buccal/lingual-palatal ) 3. 6mm apically to the peak ridge (buccal/lingual-palatal ) Measurement of alveolar ridge height: Measured distance between the summit crater and the peak of the ridge and the center line connecting the CEJ of adjacent teeth
次要结局
- Post operative adverse effects(immediate after the extraction and until 4 monthes after)