Effect of Topically Applied Melatonin (N-ACETYL-5-METHOXY TRYPTAMINE) Loaded Gelatin Sponge on Palatal Wound Healing (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- palatal wound healing
研究概览
简要总结
The aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.
详细描述
Autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. The most common site for harvesting soft tissue grafts is the palate. Many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. Unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. In order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.
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
This study will be double-blinded where the patients and the statistician will be unaware of the treatment assignment till the end of the trial.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of smoking.
- •Patients who have any known disease that interfere with periodontal surgery.
- •Patients who have any dermal or autoimmune diseases.
- •Patients who have any previous adverse reactions to the products (or similar products) used in this study.
- •Pregnant and lactating women.
- •Patients who have a palatal infection.
研究组 & 干预措施
Melatonin group
Melatonin loaded Carbopol hydrogel will be synthesized as follows: 1 gm of Carbopol will be dissolved in 100 ml deionized water while stirring at 600 rpm for 25°C. Melatonin (3gm) will be dissolved in 1 ml ethanol and added to the formed gel while stirring at 600 rpm at 25 °C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed and it will be loaded on gelatin sponge and will be applied to the donor site.
干预措施: Melatonin (Drug)
Placebo group
•Topical placebo carbopol gel will be prepared as follows: 1 gm of Carbopol will be dissolved in 100ml deionized water while stirring at 600 rpm for 25°C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed
干预措施: Carbopol (Drug)
结局指标
主要结局
palatal wound healing
时间窗: Up to 2 weeks
Standardized clinical photographs of the palatal surgical sites will be taken and will be imported into a software program (ImageJ 1.49v) and wound areas will be calculated by computerized planimetry (Difference in remaining wound area \[mm2\])
次要结局
- Intensity of pain(Up 2 weeks)
研究者
Salma Nabil
principle investigator
Alexandria University