Assessment of the Effect of Covered Versus Uncovered Human Amniotic Membrane In Soft Tissue Healing During Alveolar Ridge Preservation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Soft tissue healing
研究概览
简要总结
Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
详细描述
The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.
materials and methods
Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.Patients who need simple teeth extractions.
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.
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 in mm
次要结局
- post operative pain(every day for the first week, day after day second week, once in third and fourth week)