COMPARISON OF HARD AND SOFT TISSUE CHANGES OF SOCKET PRESERVED WITH INDIGENOUSLY PREPARED DEMINERALISED FREEZE DRIED BONE ALLOGRAFT(DFDBA) & AMNION CHORION MEMBRANE(ACM) VS. SPONTANEOUS HEALING OF THE SOCKET: A CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The test sites expected to show a better preservation of width and thickness of keratinized tissue when compared to control sites.
研究概览
简要总结
The AIM of my study is To evaluate the hard and soft tissue changes of extraction sockets with and without ridge preservation using indigenously prepared DFDBA &amnion chorion membrane (ACM). The study will comprise of 24 adult subjects of either sex with single rooted teeth having normal adjacent tooth on either side ,of either jaw, as defined in the inclusion criteria and agree to sign the informed consent.The subjects will be recruited from the Outpatient Department of Periodontics at Maulana Azad Institute of Dental Sciences.
Test group- Socket preservation with DFDBA block graft and amnion chorion membrane.
After atraumatic extraction of the tooth the socket will be preserved using DFDBA bone graft and Amnion-chorion membrane .The subjects will be recalled after a period of 6 months for evaluation of the hard and the soft tissue changes of the extraction socket and comparing it with unassisted healing of the socket.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex between the age group of 18-55 years, who are willing to sign informed consent form for the study.
- •2.Subjects in whom extraction is indicated in single rooted tooth in maxilla and /or mandible with intact adjacent teeth for stent fabrication and placement.
- •3.Clinical root length/residual socket depth should be >8 mm.
- •4.To select only sites where the tooth location and root angulation is consistent with the ideal implant orientation where inter-occlusal distance is adequate for a dental implant placement.
排除标准
- •Teeth adjacent to extraction socket having any periapical and/or active periodontal disease.
- •Pregnant women and/or expected pregnancy during the study period.
- •lactating women.
- •smokers smoking more than 10 cigarrete per day.
- •subjects under long term bisphosphponate therapy.
结局指标
主要结局
The test sites expected to show a better preservation of width and thickness of keratinized tissue when compared to control sites.
时间窗: AT BASE LINE AND 6 MONTHS
The horizontal bone resorption at the test sites expected to be 1.6 ± 0.55 mm less as compared to control group.
时间窗: AT BASE LINE AND 6 MONTHS
The vertical bone resorption at the test sites expected to be 1.1± 0.5 mm less as compared to test group.
时间窗: AT BASE LINE AND 6 MONTHS
次要结局
- The control sites are expected to require an additional bone augmentation at implant placement, when compared to the test sites.(Test sites are expected to allows the placement of longer and wider implants when compared to implants inserted in control sites .)