The Effect of Locally Delivered Melatonin Gel as an Adjunctive to Non-surgical Periodontal Therapy in the Management of Stage II Grade B Periodontitis: a Split-mouth Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in clinical attachment loss
研究概览
简要总结
Background: Periodontitis is a chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, driven by an imbalance between bacterial pathogens and the host immune response. This inflammatory process leads to the excessive production of reactive oxygen species (ROS), causing oxidative stress and tissue damage. Melatonin is a potent antioxidant and immunomodulator that scavenges free radicals and reduces inflammation. Previous research indicates that salivary and gingival crevicular fluid (GCF) melatonin levels are significantly reduced in patients with periodontitis compared to healthy individuals, suggesting its potential utility as a biomarker for periodontal health.
Aim: The aim of this study is to evaluate the efficacy of 2% melatonin gel administered locally into periodontal pockets as an adjunct to subgingival instrumentation in patients with Stage II Grade B periodontitis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients diagnosed with Stage II Grade B Periodontitis
- •Patients with good oral hygiene compliance
排除标准
- •Smokers (due to the effect of smoking on melatonin levels and healing)
- •Pregnant or lactating females.
- •Patients who have received antibiotics, anti-inflammatory drugs, or antioxidant supplements within the last 6 months.
- •Patients taking systemic melatonin for sleep disorders.
- •Patients who have undergone periodontal therapy in the last 6 months.
研究组 & 干预措施
Test Group
干预措施: 2% Melatonin gel (Other)
Control
干预措施: Placebo Gel (Other)
结局指标
主要结局
Change in clinical attachment loss
时间窗: Baseline and 8 weeks
Measurements will be recorded using a graduated William's periodontal probe
次要结局
- Change in Probing Pocket Depth(Baseline and 8 weeks)
- Change in Bleeding on probing(Baseline and 8 weeks)
- Change in Melatonin levels in Gingival Crevicular Fluid(Baseline and 8 weeks)