Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- number of of colony forming units
研究概览
简要总结
This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction.
详细描述
The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower
Grouping:
30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file.
Then the children will be randomly sub grouped according to irrigant that will be used:
Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures :
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age group 4 -8 years.
- •good health.
- •No recent history of antibiotic coverage for at least two weeks
- •necrotic teeth.
- •restorable tooth structure.
排除标准
- •more than 2/3 resorption of root.
- •uncooperative patient.
- •detection perforation on radiograph.
结局指标
主要结局
number of of colony forming units
时间窗: 48 hours after culture
number of of colony forming units less the better instrumentation technique and irritant
次要结局
未报告次要终点
研究者
Menna Mahgoub
principle investigator
Mansoura University