EVALUATION OF AN INNOVATIVE RESORBABLE MAGNESIUM-MESH INCORPORATED COLLAGEN MEMBRANE USED ALONE OR IN COMBINATION WITH DEMINERALIZED FREEZE-DRIED BONE ALLOGRAFT IN CASES OF SOCKET PRESERVATION: A LONGITUDINAL STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving alveolar crestal height.
研究概览
简要总结
Introduction – Socket preservation using barrier membranes or a combination of membranes with bone graft ensure that the alveolar ridge retains its dimension after extraction. Collagenous membranes are used as barrier membrane but has the disadvantage of collapse into the socket. Where Magnesium mesh being biocompatible and degradable can be combined with collagen membrane for additional volume stability.
Objective - To radiographically evaluate the efficacy of an innovative Magnesium-mesh incorporated collagen membrane used alone or in combination with demineralized freeze-dried bone allograft in cases of socket preservation, over a period of 6 months.
Methodology – The need for surgery and the outcome of it will be explained to the 10 patients with atleast 3 teeth indicated for extraction, following which a verbal and written consent will be obtained.
Following extraction of teeth, Sockets will randomly divide into three groups-
Group 1 -Magnesium-mesh incorporated collagen membrane alone.
Group 2 -DFDBA with Magnesium-mesh incorporated collagen membrane.
Group 3 –Spontaneous healing.
Radiographic parameters to be assessed at baseline and after 6 months.
CBCT evaluation of the socket fill and alveolar crestal height to be done using carestream CS 9300 machine.
Proposed conclusion – It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving alveolar crestal height.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with atleast three teeth indicated for extractions.
- •2.Socket depth ≥ 5mm and width ≥ 3mm.
排除标准
- •1.Pregnant and lactating women.
- •2.Subjects with intraoral periapical lesion.
- •3.Subjects with history of Magnesium allergy and subjects on bisphosphonates therapy.
结局指标
主要结局
It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving alveolar crestal height.
时间窗: Baseline , 6 months
次要结局
- It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving socket fill.(Baseline , 6 months)