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临床试验/CTRI/2016/10/007332
CTRI/2016/10/007332招募中4 期

COMPARISON OF EFFICACY AND ACCEPTABILITY OF CARIES REMOVAL METHODS : CARIE CARE WITH ATRAUMATIC RESTORATIVE TREATMENT AND CONVENTIONAL METHOD - A RANDOMIZED CONTROLLED CLINICAL TRIAL

MalavikaJ1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年12月21日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
acceptability and efficacy of caries removal methods

研究概览

简要总结

objectives: to evaluate and compare the efficacy of caries removal,time taken,pain experienced and patient acceptance of chemomechanical caries removal method with that of atraumatic restorative treatment and conventional method.

materials and methods:this will be a randomized controlled clinical trial, study will be conducted in the department of public health dentistry the oxford dental college,the oxford medical college,puttenahalli peripheral centre bangalore. this study sample consists of 75 children 5-9 years old selected from schools or opd.all children who met inclusion and exclusion criteria  are selected.a total of 120 carious teeth is selected and divided into three groups for the ART, conventional method and chemomechanical caries removal methods. the efficacy of caries removal methods is assessed by visual inspection and tactile sensation.the time taken for caries removal methods is noted from the start of the procedure till the end using stop watch.pain threshold is evaluated using visual analog scale, acceptability of the three methods is assessed by the following questions,how did you experience the  treatment,how did you find the taste,how did you find the smell.the efficacy of caries removal methods is analysed by chi square test,the pain threshold and time taken using anova followed by post hoc analysis and acceptability by using chi- square test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • •School going children who are in the age group of 5-9 years and who are willing to participate in the study, with consent form signed by parents.
  • •Patients with one or more open occlusal carious lesions of primary teeth on different quadrants.

排除标准

  • •School children who are not co-operative and not willing to participate in the study.
  • •Teeth with deep carious lesions involving pulp •Teeth with proximal carious lesions •Teeth with clinical signs and symptoms of pulpal and periapical lesions •Children with presence of any systemic illness.

结局指标

主要结局

acceptability and efficacy of caries removal methods

时间窗: immediately

次要结局

  • pain and time taken,(immediately)

研究者

发起方
MalavikaJ
申办方类型
Other [self]

研究点 (1)

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