Evaluation of the Host Modulating Effects of 1% Curcumin Chips as an Adjunct to Non Surgical Mechanical Debridement in the Treatment of Periodontitis: A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cytokine parameter
研究概览
简要总结
The study will follow a parallel arm, randomised, double blinded, placebo controlled design.
There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks) Interleukin 1 beta in GCF
Statistical analysis Repeated measures of ANOVA Paired t-tests
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy individuals
- •Presence of a minimum of 20 teeth in the oral cavity
- •Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP)
排除标准
- •Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose
- •Systemic diseases and/or Inflammatory conditions, Obesity
- •Former or current tobacco users
- •Chronic consumption of alcohol
- •Use of anti-inflammatory drugs and antibiotics over the past 3 months
- •Periodontal therapy in any form, surgical or non surgical in the past 6 months
- •Pregnant and lactating mothers
研究组 & 干预措施
1% curcumin chip
Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement)
干预措施: 1 % curcumin chip (Drug)
1% curcumin chip
Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement)
干预措施: Scaling and root planing (Procedure)
Placebo chip
Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement)
干预措施: Placebo chip (Other)
Placebo chip
Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement)
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
Cytokine parameter
时间窗: Change from Baseline to 4 weeks
Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter
次要结局
- Probing pocket depth(Changes from Baseline to 4 weeks and 12 weeks)
- Clinical attachment level(Changes from Baseline to 4 weeks and 12 weeks)
- Plaque index by Silness and Loe in 1964(Baseline from. 4 weeks, 12 weeks)
- Gingival Bleeding Index by Loe and Silness in 1963(Changes from Baseline to 4 weeks and 12 weeks)
研究者
Dr. Riya Achamma Daniel
Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
KLE Society's Institute of Dental Sciences