Evaluation of Obturation Quality in Necrotic Primary Molars After Manual Versus Rotary Pulpectomy; a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- parental acceptance
研究概览
简要总结
Forty cases of necrotic primary molars in children aged 4-8 years were selected to compare the effect of manual versus rotary pulpectomy regarding parental acceptance and obturation quality.
详细描述
The present study was performed in the Department of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.
Ethical approval was obtained from the Ethical Committee board of Faculty of Dentistry, Cairo University, Egypt.
Written informed consent was taken from the legal guardian of each participating child willing to participate in the trial, prior to the start of the clinical procedure after explaining the whole procedure in a simple way. The consent form was written in Arabic.
A sample of 40 primary mandibular second molars of children between 4 and 8 years of age indicated for pulpectomy participated in this double-blinded randomized controlled trial. Parallel allocation design was adopted for the intervention and control arms with allocation ration 1: 1 (i.e. 20 cases each). The sample size was calculated considering the previously published studies with 95% power in detecting the true statistical significance among the two groups.
Control group one: Manual pulpectomy using) H files, Mani*) Group two: Rotary pulpectomy using (Fanta baby* rotary files and Endo Radar* rotary device).
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 (Investigator, Outcomes Assessor)
盲法说明
Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till finishing the procedure of caries removal and access cavity. Blinding cannot be done during root canal instrumentation because of visual differences between manual and rotary files.
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
- •Medically free children.
- •Age: 4-8 years
- •Primary molars with necrotic pulp, abscess or fistula.
- •Teeth which if lost possibility of space maintainer construction exists.
- •Pre-operative radiograph showing absence of root resorption more than one third of the root.
排除标准
- •Vital primary teeth.
- •Teeth with inadequate tooth structure to support the rubber dam.
- •Expected shedding time within one year.
- •Peri-radicular involvement extending to the permanent tooth bud.
- •Excessive internal& external root resorption,
- •Perforation of pulpal floor.
- •Extensive tooth mobility
研究组 & 干预措施
Rotary pulpectomy
Rotary pulpectomy using rotary files (Fanta AF baby* rotary files and Endo Radar* rotary device
干预措施: Rotary pulpectomy (Procedure)
Manual pulpectomy
Manual pulpectomy using manual H files, Mani*)
干预措施: Manual pulpectomy (Procedure)
结局指标
主要结局
parental acceptance
时间窗: Immediately after the intervention
done by the participating parents who ranked their acceptance to pulpectomy procedures on a five-point Likert scale, as follows: 1, strongly acceptable; 2, acceptable; 3, neutral; 4, unacceptable; and 5, strongly unacceptable. (Scores from 1-3 means better outcome)
次要结局
- obturation quality(Immediately after the intervention and after 6 months)