Comparative Evaluation of Ozonated Olive Oil and EDTA as Lubricants and their Impact on Instrumentation Time, Postoperative Pain and File Morphology during Pulpectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Instrumentation time
研究概览
简要总结
This study is a prospective, randomized, double-blind controlled clinical trial conducted over 6 months. It aims to compare Ozonated Olive Oil and 17% EDTA as lubricants during pulpectomy in 40 children aged 4 to 8 years requiring treatment in mandibular primary molars. Participants will be randomly assigned into two groups with 20 in each group using a computer-generated randomization method with allocation concealment.
The study evaluates three main outcomes that includes instrumentation time which is recorded from glide path establishment to completion of rotary canal preparation, postoperative pain which is assessed at 6 hours, 12 hours, 1st, 3rd, and 7th day using the Modified Wong–Baker FACES Pain Rating Scale, and surface topographical changes of rotary files which is analyzed after every 5teeth. Ethical clearance has been obtained, and written informed consent and assent will be secured before participation. Obturation will be performed on the seventh day using zinc oxide–ozonated olive oil paste following pain assessment.
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
- •1.Healthy cooperative children aged 4-8 years 2.Mandibular primary molars with irreversible pulpitis devoid of any other diseased teeth in that quadrant that bothers the patient 3.No history of analgesic use 12 hours prior to pulpectomy.
排除标准
- •1.Uncooperative children 2.Children with systemic illness 3.Teeth with clinical and radiographic contraindications for pulpectomy.
结局指标
主要结局
Instrumentation time
时间窗: assessed in minutes at the same day using stop watch from the beginning of rotary instrumentation till the end of preparation
次要结局
- File Morphology evaluation under Scanned Electron Microsc0py(each rotary file after using for every 5 teeth)
- Post operative pain(6 hours, 12 hours, 1st day, 3rd day and 7h day postoperatively)
研究者
Dr Cherukuri Nikitha Saranya
GITAM Dental College and Hospital