Clinico-Radiographic Comparison of Cross Sling Suture with Conventional Sling Suture in the Surgical Management of Class II Furcation Defects – A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Volumetric measurement of bone defect at test sites using cone beam computed tomography
研究概览
简要总结
Background: Primary closure of the flap after regenerative periodontal surgery for management of class II furcation defects has been commonly done by using interdental direct loop sutures or sling sutures. However, it has been observed that the middle one third of the flap may gape open when using such sling sutures, leading to possible contamination of the regenerative material. Hence a suture called as Gomes’ cross sling suture has been designed to sling the middle third portion of the flap in addition to the interdental sling component, by encompassing another sling around the tooth.
Need of study: There is need to study the effects of using a Gomes’ cross sling suture in periodontal regenerative surgery for class II furcation defects in molars and compare the changes in periodontal parameters when using Gomes’ cross sling suture and conventional suture techniques for such surgeries.
Materials and Methods: Periodontal regenerative surgery will be performed in a cohort of twenty participants presenting with class II furcation defects in molars and indicated for such surgery using bone graft material and GTR membrane. Ten participants will be randomly allotted to control group wherein the furcation defect site will be sutured with conventional sling suture after the regenerative surgery, while in the other ten participants the Gomes’ cross sling suture will be utilized. Periodontal parameters like Plaque index, Gingival index, Sulcus Bleeding index, Mobility index, sulcus probing depth, relative vertical clinical attachment level, relative horizontal clinical attachment level and relative gingival marginal level will be assessed and compared in both groups at time-points of baseline (just before surgery) and 3-months and 6-months after surgery. Cone beam computed tomographic analysis of the furcation defect will be done at baseline and 6-months after surgery. These outcome variables will be compared using standard tests of statistical significance at a level of significance p≤0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •free of any systemic diseases such as diabetes and hypertension and has no contraindication for performing periodontal surgery,
- •having one class II furcation defect in molars, that is determined clinically by instrumentation with a curved Nabers’ probe and confirmed by IOPA Radiographs.
排除标准
- •periodontal surgeries performed in the areas to be treated within last 12 months
- •presence of infections other than periodontal infections at the site to be treated, like endodontic infections.
- •smokers, smokeless tobacco users, known addiction of alcohol, immunocompromised patients, pregnant and/or lactating women.
- •has taken antibiotics in any form in the past 3 months,
- •unable to or not willing to come for routine follow-up for 6 months after periodontal surgery,.
结局指标
主要结局
Volumetric measurement of bone defect at test sites using cone beam computed tomography
时间窗: R0- Before the surgical procedure | R6- 6 months after surgical procedure
次要结局
- 1. Plaque Index (Silness & Löe, 1964)(2. Gingival index (Löe & Silness, 1963))
研究者
Dr Shraddha Gupta
Uttaranchal Dental and Medical Research Institute