Efficacy of subgingivally delivered curcumin gel and tetracycline fibres as an adjunct to scaling and root planing: A clinico-biochemical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Reduction in CAL and PPD
研究概览
简要总结
This study outlines the effectiveness of subgingivally delivered curcumin gel and tetracycline fibres as adjuncts to scaling and root planing (SRP) in treating chronic periodontitis (CP). This randomized controlled trial will include 54 systemically healthy patients (18-65 year) suffering from CP with pocket depths of at least 5mm. The study will divide participants into two groups- one receiving SRP followed by tetracycline fibres (control group) and the other receiving SRP followed by curcumin gel (test group). The primary objectives are to compare the reduction in Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD). Secondary objectives include assessing the Plaque index (PI), Modified Sulcular Bleeding Index (mSBI) and Interleukin-1 beta (IL-1 beta) biomarker levels. The study aims to determine if curcumin gel with SRP offers an added benefit in reducing pocket depth and CAL. The assessment of Interleukin-1 beta biomarker levels a pro-inflammatory cytokine elevated in periodontitis and contributing to attachment loss will provide biochemical insights into the anti-inflammatory efficacy of these adjunctive therapies.
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 Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female patients of 18-65 years of age, who are willing to give written informed consent.
- •Patients with chronic periodontitis with presence of at least two periodontal pockets of greater than or equal to 5mm in the contralateral arch.
- •Systemically healthy individuals.
排除标准
- •Patients who have taken antibiotics or have undergone periodontal therapy in last 3 months.
- •Medically compromised patients, mentally disabled and physically handicapped patients.
- •Pregnant women and lactating mother.
- •Patients allergic to tetracycline or curcumin gel.
- •Patients having deleterious habits.
结局指标
主要结局
Reduction in CAL and PPD
时间窗: CAL- 0, 15 days, 3 months | PPD- 0, 15 days, 3 months
次要结局
- PI, mSBI, Interleukin-1 beta(PI- 0, 15 days, 3 months)
研究者
Karnika Agrawal
Kothiwal Dental College and Research Centre, Moradabad