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临床试验/CTRI/2024/02/063229
CTRI/2024/02/063229招募中不适用

A comparative assessment of clinical efficacy of various types of pulp capping agents in primary teeth- A prospective randomized clinical study.

Siddhi Kamble1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
To assess the dentin bridge formation after the use of various types of pulp capping

研究概览

简要总结

This is a prospective randomized clinical study. 75 Teeth will be divided into four groups.  

Group A – Biodentin 

Group B – Neo MTA

Group C- MTA- HP

Group D – Theracal

Group E - Neo Liner

CLINICAL PROCEDURE

-administration of local anesthesia.

-Isolation of teeth using rubber dam.

-Cavity preparation using diamond burs (330 SS white) at high speed with water coolant.

-caries removal with a spoon excavator according to principles of minimally invasive dentistry (All of the caries will be excavated from cavity walls to ensure adequate bonding. The infected dentin will be excavated leaving behind a thin layer of affected dentin when the pulp is approximated. removal of all infected dentin is ensured for which Cavity disinfectant is used.

-Then various Indirect pulp capping materials such as Biodentine, Neo MTA, MTA- HP, Theracal, Neo Liner will be placed in cavity according to the manufacturer’s instructions.

-Followed by final restorative material.

FOLLOW UP

Follow up of the restorations will be set at 1 week, 3 months and 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
3.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children between 3 and 9 years no history of spontaneous pain International Caries Detection and Assessment System (ICDAS) 5+ criteria.

排除标准

  • presence of interradicula,periapical pathology sinus,fistula, internal resorption pathologic mobility parents not willing to be part of study.

结局指标

主要结局

To assess the dentin bridge formation after the use of various types of pulp capping

时间窗: 1 week, 3 months and 6 months

agents in primary teeth. The dentin bridge formation will be assessed radiographically

时间窗: 1 week, 3 months and 6 months

次要结局

  • The presence of post operative pain, swelling will be evaluated after the application of various types of pulp capping(agents in primary teeth. These will be clinically evluated .)

研究者

发起方
Siddhi Kamble
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Siddhi Kamble

M.A. Rangoonwala College of Dental Science and Research Center

研究点 (1)

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