临床试验/CTRI/2025/07/090547

CTRI/2025/07/090547尚未招募不适用

Therapeutic Effectiveness of Virgin Coconut Oil versus Chlorhexidine in the Management of Recurrent Aphthous Ulcer in Children: A Randomized Clinical Trial.

Department of Pediatric and Preventive Dentistry1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2025年7月25日最近更新: 2025年7月8日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 48
试验地点: 1
主要终点: 1.Pain Reduction

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized single-blinded interventional trial, comparing the effectiveness of Virgin Coconut Oil and Chlorhexidine gel in managing Recurrent aphthous ulcers in children aged 11-14 years. A total of 48 participants will be equally divided into two groups. Outcomes like Pain, ulcer size and erythema will be measured on day 0,1,3 and 7. The study uses block randomization with sealed envelope allocation. The study is expected to be completed by one year.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 11.00 Year(s) 至 14.00 Year(s)（—）
性别: All

入选标准

•Children with recurrent minor oral aphthous ulcers (up to 6mm).

排除标准

•1.Patients with a history of any systemic disease 2.Traumatic ulcers 3.Patients on any recent topical or systemic antibiotics or analgesics 4.History of dental surgery within one month.

结局指标

主要结局

1.Pain Reduction

时间窗: Day 0 (Baseline) | Day 1 | Day 3 | Day 7

2.Ulcer size reduction

时间窗: Day 0 (Baseline) | Day 1 | Day 3 | Day 7

3.Erythema level

时间窗: Day 0 (Baseline) | Day 1 | Day 3 | Day 7

次要结局

Complete Healing Achieved(Day 7)

研究者

发起方

Department of Pediatric and Preventive Dentistry

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Aysha Lubna Salim

Kannur Dental College

研究点 (1)

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