Time Efficiency and Obturation Quality of Rotary Files Versus Manual Files in Pediatric Endodontics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Is to evaluate the time efficiency of the rotary mm files versus manual stainless steel k files in the pulpectomy of lower second primary molars affecting the positive behavior of the child
研究概览
简要总结
The aim of this study is to evaluate the quality of obturation and the time efficiency of rotary versus manual instrumentation in roots of deciduous molars clinically where the:
- Primary objective Is to evaluate the time efficiency
- Secondary objective Is to evaluate the quality of obturation Clinical and radiographical follow up will be performed for 18 months to investigate the clinical and the radiographic success for the Conventional and Rotary groups.
详细描述
The study will be conducted in two parts as follows:
In-vitro part as a training part to practice, test the speed of the rotary system, followed by application clinically.
Obturation will be done using two different filling techniques:
- Incremental filling Technique
- Disposable syringe Technique.
Then the instrumentation time and the quality of obturation will be recorded.
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 (Participant)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children included in the study should conform to the following criteria:
- •Patients between ages 4-7 years old with at least one mandibular vital or non-vital primary molar indicated for pulpectomy will be selected.
- •Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.
- •No physiological root resorption.
- •The teeth should have enough coronal structure for full coverage Stainless-Steel crowns.
排除标准
- •Children who are extremely uncooperative and difficult to manage
- •Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN)
- •Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.
研究组 & 干预措施
Rotary instrumentation using MM files 1
Rotary instrumentation using MM files (IMD Inc, China), sizes 20-25-30 taper 0.4, length 16 mm, then obturation with Zinc oxide and Eugenol using Incremental filling Technique.
干预措施: NSK Endo motor Endomate (Procedure)
Manual instrumentation using K-files 1
Manual instrumentation using K-files (Mani Inc, Tochigi, Japan), sizes 15-20-25-30-35 then obturation with Zinc oxide and Eugenol using Incremental filling Technique.
干预措施: manual K-files (Procedure)
Rotary instrumentation using MM files 2
Rotary instrumentation using MM files (IMD Inc, China), sizes 20-25-30 taper 0.4, length 16 mm, then obturation with Zinc oxide and Eugenol using Disposable syringe technique.
干预措施: NSK Endo motor Endomate (Procedure)
Manual instrumentation using K-files 2
Manual instrumentation using K-files (Mani Inc, Tochigi, Japan), sizes 15-20-25-30-35 then obturation with Zinc oxide and Eugenol using Disposable syringe technique
干预措施: manual K-files (Procedure)
结局指标
主要结局
Is to evaluate the time efficiency of the rotary mm files versus manual stainless steel k files in the pulpectomy of lower second primary molars affecting the positive behavior of the child
时间窗: up to 18 months
Time efficiency of instrumentation using rotary mm files specially designed for primary teeth versus manual stainless steel K-files in the pulpectomy of mandibular second primary molars, by clinical and radiographic evaluation for 18 months.
Is to evaluate and compare the quality of obturation using two different obturation techniques following instrumentation by rotary mm files and manual stainless steel k files instrumentation in another group
时间窗: up to 18 months
The quality of obturation using ZOE will be performed with either the incremental technique or the modified disposable syringe technique, following instrumentation by rotary and manual files, where the grading will be as : 1: overfilled, 2: underfilled 3: optimum filling.
次要结局
未报告次要终点
研究者
Reem Mahmoud Abdelkader Awad
assistant lecturer
British University In Egypt