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临床试验/CTRI/2025/02/081336
CTRI/2025/02/081336尚未招募2 期

Patient Comfort and Acceptance of Different Isolation Techniques for Silver Diamine Fluoride Application

dy patil school of dentistry navi mumbai1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
Comfort of three different types of isolation techniques in primary molars during silver diamine fluoride application

研究概览

简要总结

The aim of the present study will be to evaluate and compare the comfort and acceptance of three different methods of isolation- Cotton roll, OpalDam and OptraDam during silver diamine fluoride application in primary mandibular molars in children.

The children will be randomly divided into 3 groups based on computer-generated randomization. 39 children having at least one carious primary mandibular molar will be included in this study.

Group I (n = 13): The participants will receive cotton roll isolation prior to silver diamine fluoride application.

Group II (n = 13): The participants will receive Opaldam isolation prior to silver diamine fluoride application. A thick layer of 4-6 mm of Opaldam resin will be applied on the gingiva to seal the interproximal spaces and 0.5 mm onto dry enamel to seal the tooth. Light cure in scanning motion for 20 secs.

Group III (n=13) - The participants will receive Optradam isolation according to manufacturer’s instructions prior to silver diamine fluoride application.

In all three groups, silver diamine fluoride will be applied to the tooth using a bent microsponge brush. The brush will be dipped into the SDF and then dabbed on the side of a plastic dappen dish to remove excess liquid before application. The application time will be at least one minute, if possible. Afterward, a gentle flow of compressed air will be used until the medicament will be dry. Efforts will be made to maintain isolation for up to three minutes. Assessment will be performed using Wong-Baker FACES pain rating scale and Patient Satisfaction questionnaire will be given to the patient. High vacuum suction and Vaseline will be used with all the three isolation groups for standardising the procedure. The first part of the questionnaire will include data regarding age, gender, and each patient’s previous experience with dental isolation. The second part will consist of six questions on a numerical scale from zero to 10 for the subjects to rate their experiences in relation to noise, gagging sensation, fluid leaking, stretching pressure, and discomfort associated with the isolation systems. Zero on the numerical scale represented the complete absence of the irritating factors, while 10 represented the presence of the irritating factors at all times during the procedure except the last question, where zero represented discomfort during isolation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Children in the age group of 5-9 years with moderate caries in primary mandibular first and second molars.
  • Children having no history of allergy against silver particles or latex.
  • Parents who gave consent for discoloration after silver diamine fluoride application.

排除标准

  • Children with pulpal carious primary molars.
  • Children having psychological disorders, under medications with systemic illness.

结局指标

主要结局

Comfort of three different types of isolation techniques in primary molars during silver diamine fluoride application

时间窗: Baseline

次要结局

  • Acceptance of three different isolation techniques in primary molars during silver diamine fluoride application(Baseline)

研究者

发起方
dy patil school of dentistry navi mumbai
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shirin Chavan

basement room no. zero department of pediatric and preventive dentistry, DY Patil school of dentistry sector 7 nerul navi mumbai Maharashtra 400706 india

研究点 (1)

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