CTRI/2022/12/048262尚未招募4 期
Evaluation of the effect of systemically administered melatonin in patients undergoing regenerative surgical periodontal therapy- a double blind placebo controlled clinical trial
Other self1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月25日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Level of alkaline phosphatase and bone sialoprotein at baseline and 4 weeks after intervention
研究概览
简要总结
Melatonin is secreted by the pineal gland in circadian cycles, mainly during sleep. However, a small portion is also produced by the salivary glands. Therefore, we chose melatonin to test if it might contribute to the prevention of severe oral inflammation and improve the bone regeneration compared to patients without melatonin supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant 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
- •1.systemically healthy Subjects with periodontal disease indicated for flap surgery
- •Subjects with three/two walled intrabony defects that can be regenerated.
排除标准
- •Subjects without periodontal disease
- •Subjects with periodontal disease not requiring regenerative therapy.
结局指标
主要结局
Level of alkaline phosphatase and bone sialoprotein at baseline and 4 weeks after intervention
时间窗: at baseline and 4 weeks after intervention
次要结局
- Clinical parameters: probing depth, clinical attachment loss(Base line, 3 months)
- Levels of melatonin(Baseline, 1 month)
研究者
研究点 (1)
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