Comparative Evaluation of Minimally Invasive Nonsurgical Periodontal Therapy Versus Conventional Subgingival Instrumentation in Patients With Generalized Stage 2 and 3 Periodontitis - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of diseased sites
研究概览
简要总结
Background- The use of minimally invasive procedures has recently been advocated for the treatment of periodontitis, to minimize patient discomfort and maximize the healing potential. These techniques usually involve the use of magnification lenses or microscopes and small instruments which reduce the risk of tissue trauma compared with traditional instruments.
Rationale- So far only descriptive data about the clinical effects of such procedure are available and comparative studies that would include other treatment alternatives are lacking. Therefore, the aim of this study is, on split-mouth model, to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on probing) after conventional subgingival instrumentation and Minimally invasive nonsurgical periodontal therapy (MINST) with the usage of special mini instruments and magnifying loupes.
Objectives- To compare sites that have residual probing depth and require further surgical intervention after undergoing the two treatment modalities.
Methods- In this split mouth randomized controlled trial, Test group will undergo non surgical therapy under magnification and using special mini bladed instruments while the control group will undergo conventional subgingival instrumentation. Reevaluation will be at 6 weeks and 3 months.
Expected outcomes- If both the groups differ in outcomes after therapy, MINST can be used to minimize the number of sites that require surgery and hence will reduce treatment costs and morbidity.
详细描述
Aim and objectives- The aim of this study is to evaluate the clinical outcomes after minimally invasive nonsurgical periodontal therapy versus after conventional scaling and root planing in stage 2 and stage 3 generalised periodontitis patients.
Primary Objective- 1. Comparative evaluation of number of sites with residual pocket depth > 4 mm and bleeding on pocket probing after MINST versus conventional SI at the end of 6 weeks and 3 months Secondary objective-
- Comparative evaluation of periodontal parameters viz. probing depth, clinical attachment level, gingival recession, treatment time and patient reported outcomes after MINST versus conventional SI at the end of 6 weeks and 3 months.
Methodology- Study design- This randomized controlled trial will be conducted in the department of Periodontics, Post graduate institute of dental sciences (PGIDS), Rohtak in accordance with the ethical standards outlined in the declaration of Helsinki 1975, as revised in 2013.The study design was approved by Institutional review board, PGIDS, Rohtak and ethical acceptance applied for from the Ethical committee of PGIDS, Rohtak. Patients coming to the out patient department of Periodontics, after examination, will be included in the study if they meet the following inclusion criteria.
Randomisation- It is a split mouth study so 2 quadrants within the same arch (intra arch) in each patient will be randomly allocated to test group and control group. For the randomization process, a computer-generated list will be used to define side and treatment modality.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of diseased sites
时间窗: 6 weeks and 3 months
Difference in No of Sites with PPD (probing pocket depth) \> 4 mm and BOP (bleeding upon probing)
次要结局
- CLINICAL ATTACHMENT LEVEL(CAL)(6 WEEKS AND 3 MONTHS)
- PROBING POCKET DEPTH(PPD)(6 WEEKS AND 3 MONTHS)
- GINGIVAL RECESSION(REC)(6 WEEKS AND 3 MONTHS)