Assessment of Amnion Membrane Versus Chorion Membrane for Soft Tissue Healing After Tooth Extraction; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Soft tissue healing
研究概览
简要总结
Statement of the problem: Tooth extraction results in hard and soft tissue loss which complicates prosthodontic rehabilitation, So different techniques of alveolar ridge preservation should be done to maintain hard and soft tissue dimensions.
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
详细描述
Aim: The aim of this study is to compare the effect of amnion membrane versus chorion membrane on soft tissue healing among socket preservation procedure.
Materials and Methods
This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in the posterior region not indicated for immediate implant placement. They will be randomly allocated to two equal groups. Group A (n=95) socket will be grafted with HAM particulate and the socket will be covered with amnion membrane, and group B (n=95) socket will be grafted with HAM particulate and the socket will be covered with chorion membrane. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.
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
- Double (Participant, Outcomes Assessor)
盲法说明
blinding of outcome assessors and participants will be achieved as the different outcomes will be assessed for all groups by assessors other than the researchers doing the procedures.
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
- •Patients who need simple extraction not indicated for immediate implant placement.
排除标准
- •Patients with inability or anticipated failure to maintain adequate oral hygiene.
- •Pregnant or breast-feeding mothers.
- •Any medical condition or therapy that can affect healing.
研究组 & 干预措施
Amnion membrane
the amnion membrane tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material
干预措施: Amnion membrane. (Procedure)
Chorion membrane.
chorion membrane (Bioxclude , Snoasis Medical , USA) tucked over the extraction socket then the socket plug will be maintained in place with approximating sutures using 5-0 resorbable suture material.
干预措施: Chorion membrane (Procedure)
结局指标
主要结局
Soft tissue healing
时间窗: every day for the first week, day after day second week, once in third and fourth week
Surface area/intraoral scanner
次要结局
- Healing index(every day for the first week, day after day second week, once in third and fourth week)