CTRI/2025/08/093388已完成2/3 期
To Compare and Evaluate the Efficacy of Ozonated Olive Oil on Postoperative Pain Haemostasis Healing following Extraction in Primary Molar: An In Vivo Study.
Hitkarini Dental College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月9日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain- VAS Scale-1 to 10
研究概览
简要总结
The study is randomised controlled trial, parallel group, comparing and evaluating the efficacy of ozonated olive oil on post operative pain, healing and haemostasis following extractions in primary molars, that will be conducted in India. The primary outcomes will be to asses haemostasis after extraction, pain after 6 hourly and 24 hourly, pain and healing on 3rd and 7th day following extraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 4 to 8 years.
- •Signed informed consent of parents or guardians for the participation of the children.
- •Children without any systemic disease.
- •Children without disability limitations.
- •Children with teeth involving abscess, pulpectomy failure, furcation involved, pathological root resorption, reinfection.
排除标准
- •Children below 4 years or above 8 years of age.
- •Children whose parent/ guardians did not sign the statement of informed consent.
- •Children with any systemic disease.
- •Children with special disabilities/mentally disabled children.
结局指标
主要结局
Pain- VAS Scale-1 to 10
时间窗: Pain 6 hourly and 24 hourly | Pain and healing 3rd and 7th day
Healing- Very Poor to Excellent
时间窗: Pain 6 hourly and 24 hourly | Pain and healing 3rd and 7th day
Haemostasis-2 to 8 minutes
时间窗: Pain 6 hourly and 24 hourly | Pain and healing 3rd and 7th day
次要结局
未报告次要终点
研究者
Dr Namrata Jain
Hitkarini Dental College
研究点 (1)
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