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临床试验/NCT06151665
NCT06151665尚未招募不适用

A Comparative Study Between Single Rotary File System and Conventional Manual K-File in Pulpectomy of Primary Molars.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Clinical and Radiographical Success

研究概览

简要总结

The sample size will be divided between two groups, Group A pulpectomy will be done using single rotary file in primary molars and group B pulpectomy will be done using manual K file system. follow up of the patients and clinical and radiographical success rates of cases will be seen.

详细描述

Each patient will have access in the primary molar and pulpectomy procedure will be done according to inclusion and exclusion criteria , the patients will be divided according to two groups Group A using single File rotary and group B manual K file system. Time will be recorded in each procedure and each patient will receive stainless steel crown. Follow up for the patients will be done clinical and radiographical success will be seen, postoperative pain will be measured and all data will be collected and statistically analyzed.

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)

盲法说明

an external pediatric Dentist will assess the radiographic and clinical follow-up of the enrolled patients

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Absence of external or internal root resorption
  • presence of two thirds of the root
  • Primary molars with deep caries and irreversible pulpitis that require pulpectomy in a single visit. Molars can be vital with a history of spontaneous pain or non-vital as indicated by absence of bleeding from the pulp.

排除标准

  • Children with physical, intellectual disability or medical conditions that may complicate treatment.
  • Teeth with poor prognosis due to the presence of a sinus, excessive mobility or advanced bone resorption.
  • Teeth with radiolucent areas in furcation regions.

结局指标

主要结局

Clinical and Radiographical Success

时间窗: 1 year

Clinical evaluation to swelling, fistula and pain on percussion by clinical examination followed by a radiographic evaluation to absence of periapical and inter-radicular radiolucency, external or internal root resorption according to radiographic images

次要结局

  • postoperative pain(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah magdy

assistant lecturer of pediatric dentistry

Ain Shams University

研究点 (1)

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