Comparative Clinical Evaluation of the Efficacy of Triphala Gel and Chlorhexidine Gel as Local Drug Delivery Agent and their Effect on Salivary Matrix Metalloproteinases-8 Levels in Chronic Periodontitis Patients. A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 3.Probing Pocket Depth (PPD).
研究概览
简要总结
The aim of the study is to evaluate and compare clinicallythe effect of Triphala gel and Chlorhexidine gel as Local Drug Delivery agentand its effect on Salivary Matrix Metalloproteinases-8 levels. A total of40npatients with chronic periodontitis will be selected from OPD of Dept. ofPeriodontics, Nair Hospital Dental College, Mumbai and will be equally dividedin two groups of which one will receive Triphala gel as LDD and Chlorhexidinegel as LDD and 20 periodontally healthy patients will be selected on which onlySalivary MMP-8 estimation will be done. The study is clinical interventional prospective study.Computer generated randomization will be done. The study duration will be of 18months of which 4 months for patient’s follow-up and 14 months for completionof project. The efficacy parameters are plaque index, gingival index, probingpocket depth, clinical attachment levels and salivary MMP-8 levels will berecorded at baseline in periodontally healthy group and at baseline, 1 month and3 months post surgery in other two groups. The data will be analyzed individuallyfor all the patients. The statistical analysis method to be used will beRepeated measure ANOVA followed by post-hoc test. There is no conflict ofinterest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in good systemic health 2.The patients ranged in age from 20 to 60 years 3.Patients with chronic periodontitis with isolated periodontal pockets.
- •(probing pocket depths [PPDs] ≥5 mm) 4.Patients with a minimum of 10 teeth in their total dentition 5.Cooperative patients who can be motivated to maintain good oral hygiene.
排除标准
- •1.Subjects who did not give consent.
- •2.Subjects using antibiotic medications, mouthwashes, chewing gums, tobacco at the time of the study or 6months prior to it.
- •3.Patients with known hypersensitivity to Chlorhexidine.
- •4.Patients with furcation involvement; 5.Subjects having any oral or systemic disease.
- •6.Pregnant and/or lactating mothers.
- •7.Patients with any bleeding disorders or on anticoagulant therapy.
- •8.Patients who had received any type of periodontal therapy for the past 6 months 9.Patients who were smokers or had tobacco in any other form.
结局指标
主要结局
3.Probing Pocket Depth (PPD).
时间窗: Outcomes assesed at Baseline, 1 month after Scaling and Root Planing and 3 months after application of LDD
4.Clinical Attachment Level (CAL).
时间窗: Outcomes assesed at Baseline, 1 month after Scaling and Root Planing and 3 months after application of LDD
1.Plaque Index (P.I.)(TURSKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN).
时间窗: Outcomes assesed at Baseline, 1 month after Scaling and Root Planing and 3 months after application of LDD
2.Gingival Index (G.I.) (LOE &SILNESS, 1963).
时间窗: Outcomes assesed at Baseline, 1 month after Scaling and Root Planing and 3 months after application of LDD
次要结局
- Salivary Matrix Metalloproteinases-8 Levels by using ELISA(Outcome assessed at baseline, 1 month after Scaling and Root planing and 3 months after LDD placement)