Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Patients With Furcation Involvement in Mandibular Molars - A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- change in horizontal clinical attachment level (HCAL)
研究概览
简要总结
The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems to result from the incomplete removal of subgingival plaque and calculus in the interradicular area owing to the peculiar anatomy of the furcation space.
Regarding the therapeutic approach, although FI treated with a conservative approach may not yield the same satisfactory results as single rooted teeth; it has been shown that teeth with FI have a remarkable survival rate following conservative treatment in patients demonstrating a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative gingival architecture, create a minimal wound and gently handle soft and hard tissues. It becomes imperative to see the differences in clinical, and patient centered outcomes of minimally invasive non- surgical versus surgical technique in the management of furcation involvement in mandibulae molar.
详细描述
Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS, Rohtak after screening based on given inclusion and exclusion criteria. after initial session of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those having grade 2 furcation involvement in any mandibular molar and meeting other eligibility criteria will be randomly allocated to test group and control group Test group -Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.
control group-Surgical technique will be followed with minimally flap reflection and incisions will be performed with papilla preservation techniques. vertical- releasing incisions will not be made, and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes. The visible calculus will be carefully removed with curettes and an ultrasonic device. The flaps will be re-positioned and sutured and patient follow up 3 to 6 months .
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients with diagnosis of generalized stage 3 periodontitis (Grade A or B) with at least one mandibular molar with FI (Degree 1 or 2-according to Hamp, 1975 and Subclass A or B- according to Tarnow and Fletcher, 1984), interproximal bone coronal to the furcation fornix and root trunk length ≤ cervical two thirds of the root length as measured on a periapical radiograph.
- •Full mouth plaque score < 30% after initial therapy
- •Full mouth bleeding score < 30% after initial therapy
- •Having undergone a course of subgingival instrumentation in the past three months
排除标准
- •Pregnant or lactating females
- •Requiring antibiotic premedication
- •Received antibiotic treatment in the previous 3 months
- •Previous periodontal surgery in the last 1 year
- •Pulpal or periapical pathology
- •Third molar
- •Non restorable tooth
- •Trauma from occlusion
研究组 & 干预措施
minimally invasive non surgical therapy
Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.
干预措施: minimally invasive non- surgical therapy (Procedure)
open flap debridement
Surgical technique will be used and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes.
干预措施: open flap debridement (Procedure)
结局指标
主要结局
change in horizontal clinical attachment level (HCAL)
时间窗: 6 months
change in horizontal clinical attachment level (HCAL) of the furcation as assessed
次要结局
- change in changes vertical clinical attachment level of furcation(3 months)
- probing pocket depth (PPD)reduction(6 months)
- changes in vertical probing depth of the furcation(6 months)
- change in vertical clinical attachment level of furcation(6 months)