NCT07316582Enrolling By Invitation4 期
Clinical and Biochemical Evaluation of Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management of Stage II Grade A Periodontitis: A Randomized Controlled Clinical Trial
干预措施
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
melatonin loaded in injectible platelet rich fibrin in treatment of 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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Diagnosed with stage II periodontitis based on AAP/EFP 2018 classification
- •Minimum of two non-adjacent periodontal pockets <5 mm in different quadrants
- •Systemically healthy individuals willing to participate and comply with follow-up visits
- •Radiographic bone loss (ranged from is 10-20% mostly horizontal
排除标准
- •History of systemic diseases affecting periodontium (e.g., diabetes, osteoporosis)
- •Use of antibiotics, anti-inflammatories, or antioxidant supplements in the past 3 months
- •Smoking or tobacco use
- •Pregnancy or lactation
- •Allergy to melatonin or related compounds
研究组 & 干预措施
Injectable Platelet-Rich Fibrin (i-PRF)
Placebo Comparator
local application of injectable platelet-rich fibrin (i-PRF) into periodontal pockets.
干预措施: injectible platelet rich fibrin (i-PRF ) (Biological)
scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin
Experimental
patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection
干预措施: Melatonin-Loaded Injectable Platelet-Rich Fibrin (Drug)
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Nora Abdelgawad Mohamed
Associate Professor of Oral Medicine, Periodontology and Diagnosis, Faculty of Dental Medicine for girls, Al -Azhar University, Cairo, Egypt
Al-Azhar University
研究点 (1)
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