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临床试验/CTRI/2024/01/061258
CTRI/2024/01/061258招募中4 期

Dental Anxiety Associated With Chemo-Mechanical Caries Removal Method, Conventional Method And Atraumatic Restorative Treatment: A Randomized Controlled Trial

Dr Anakapalli Sai Praharsh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Dental anxiety recorded using Facial Image Scale score before treatment

研究概览

简要总结

Throughout the years, many invasive methods have been developed for the removal of caries. The advancements in dentistry have made it possible to conserve the maximum amount of tooth structure possible. Individuals with high dental anxiety are often unable to utilise standard dental health services and often leads to reduced oral health-related quality of life. In light of new chemo-mechanical agents available commercially, it is important to assess their clinical efficacy and anxiety associated with them. This study aims to evaluate the anxiety levels before and after caries removal by chemo-mechanical caries removal agent, atraumatic restorative treatment (ART) and conventional methods (Rotary handpiece). This randomized controlled trial will be conducted to assess anxiety before and after caries removal by a chemo-mechanical caries removal agent (V-Carie-Solve), atraumatic restorative treatment (ART) and conventional methods (Rotary handpiece) among 30 children aged 6-14 years, divided into 3 groups (n=10 per group) based on the parameters of degree of caries removal, time for caries removal and dental anxiety experienced before and after intervention. Degree of caries removal will be assessed with a caries dye (Prevest Reveal) and time per procedure will be recorded using a stopwatch. Dental anxiety will be assessed using Facial Image Scale (FIS) before and after treatment. The data obtained will be entered into an excel sheet and appropriate statistical analysis would be carried out using SPSS v.26.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Healthy children of
  • 14 yrs of age who are willing to participate and with signed consent form by parents Teeth with a broad occlusal cavitated lesion showing brown and softened dentin clinically and radiographically.

排除标准

  • Teeth with pulpal exposures Teeth with spontaneous pain, mobility, swelling, and fistulae Teeth with furcation involvement, cervical lesions, Teeth with restorations, sealants, or enamel defects.

结局指标

主要结局

Dental anxiety recorded using Facial Image Scale score before treatment

时间窗: before treatment

次要结局

  • Dental anxiety recorded using Facial Image Scale score after treatment(after treatment)

研究者

发起方
Dr Anakapalli Sai Praharsh
申办方类型
Other [self]

研究点 (1)

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