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