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临床试验/NCT05102318
NCT05102318Unknown不适用

Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars

British University In Egypt1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

研究概览

简要总结

The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

详细描述

Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.

A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.

Subjects will be assigned randomly into two different treatment groups as follows:

MTA Group (1):

  1. Group 1(A): MTA Direct Pulp Capping. (n=25)
  2. Group 1 (B): MTA Partial Pulpotomy. (n=25)
  3. Group 1 (C): MTA Complete Pulpotomy. (n=25)

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

入选标准

  • No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
  • Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.

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.

结局指标

主要结局

Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

时间窗: 18 months

Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

次要结局

未报告次要终点

研究者

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

Marwa Magdy

Director

British University In Egypt

研究点 (1)

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