A Comparative evaluation of the efficacy of amnion chorion membrane and collagen membrane with demineralized bone graft in intrabony defects-a split mouth randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plaque index, Gingival Index, Periodontal Pocket Depth, Clinical Attachment Level.
研究概览
简要总结
A Split mouth Randomized clinical trial will be conducted. A total number of 24 sites will be chosen. Patients will be selected based on inclusion criteria.12 sites each will be randomly allocated to test (Amnion Chorion Membrane)and control (Collagen Membrane) groups. Demineralized bone matrix will be placed for the both groups. Patients will be recalled after 3 months and 6 months post operatively for recording clinical and radiographic parameters.
Clinical parameters include Plaque index(PI), Gingival Index(GI), Periodontal Pocket Depth(PPD), Clinical Attachment Level(CAL).
Radiographic parameters including BDA (Bone Defect Area), from CEJ to bottom of the IBD(Intra Bony Defect),from CEJ to Alveolar Crest ,from Alveolar Crest to base of IBD is measured using CBCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 32.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 32 to 49 years in both genders Systemically healthy patients Diagnosed with generalized chronic periodontitis Evidence of intrabony defects Pocket depth greater than 5mm.
排除标准
- •Pregnant or lactating women Patients taking any medication 3 months prior to the study Receiving any periodontal treatment 6 months prior to study initiation.
- •Former or Current smokers.
结局指标
主要结局
Plaque index, Gingival Index, Periodontal Pocket Depth, Clinical Attachment Level.
时间窗: baseline,3months and 6months
次要结局
- Bone fill(baseline and 6months)
研究者
Pendyala Neelima
GSL Dental College and Hospital