Comparative evaluation of the efficacy of local administration of Curcumin gel and Metformin gel as an adjunct to non-surgical periodontal therapy– A 3-Arm parallel randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Periodontal probing depth
研究概览
简要总结
Aim: This study is aimed to assess the efficiency of subgingivally delivered curcumin and metformin gel as an adjunct to scaling and root planning in the treatment of stage 1 periodontitis Objectives:
- To evaluate the efficacy of topically applied curcumin as an adjunct to NSPT in the treatment of stage 1 periodontitis
- To evaluate the efficacy of topically applied metformin gel as an adjunct to NSPT in the treatment of stage 1 periodontitis
- To compare the efficacy of curcumin gel and metformin gel as an adjunct to NSPT in the treatment of stage 1 periodontitis
Clinical examination will be carried out and the baseline values prior to the procedure will be recorded by a single calibrated examiner. Radiographic analysis will be done to diagnose stage 1 periodontitis. A customized acrylic occlusal stent will be fabricated for each patient to fit over the selected sites. Values will be recorded on a standardized form containing the demographic data of the patient. Scaling will be performed by ultrasonic scaler followed by SRP using specific Gracey Curettes After thorough SRP, PPD was re-determined to avoid any discrepancy due to the presence of subgingival calculus followed by the local drug application In Group I, the area will be completely dried using an air syringe and isolated with cotton rolls to prevent contamination from saliva. The local drug delivery system consisting of 1% Metformin gel (10) will be placed in the periodontal pockets by applicator tips or syringe with a needle attached to it Coe-Pak will be used to cover the pocket to retain the material in the pocket, as well as to prevent the ingress of oral fluids In Group 2 the same procedure will be repeated and a local drug delivery system consisting of 2% curcumin gel will be placed in the periodontal pockets followed by Coe-Pak In Group 3 only and scaling and root planing will be performed
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, Investigator 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
- •Patients above 18yrs of age
- •Systemically healthy patients with a minimum complement of 20 natural teeth
- •Probing depth (PD) ≤4mm
- •Clinical attachment level (CAL) 1-2mm
- •Less than 15% bone loss assessed radiographically
- •No history of periodontal therapy or use of antibiotics in the preceding 6 months.
排除标准
- •Subjects with known systemic disease;
- •Subjects with known or suspected allergy to the MF/biguanide group of drugs
- •Subjects who are allergic to curcumin in any form
- •Subjects on systemic MF for obesity
- •Subjects who consume alcoholic
- •Subjects who are immunocompromised
- •Pregnant or lactating women.
结局指标
主要结局
Periodontal probing depth
时间窗: baseline, 1 month and 3 moths
Clinical attachment level
时间窗: baseline, 1 month and 3 moths
次要结局
- Plaque index Modified Sulcular Bleeding index(baseline, 1 month and 3 moths)
研究者
Gauri Jayachandran
NITTE (Deemed to be University) AB Shetty Memorial Institute of Dental Sciences (ABSMIDS)