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临床试验/CTRI/2024/12/078741
CTRI/2024/12/078741尚未招募4 期

Effectiveness of Fluoride varnish in adjunct to Oral health education in caries prevention among prisoners of Haryana. A randomized controlled trial

Dr Kanupriya Pandey1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
Net caries increments

研究概览

简要总结

The effectiveness of fluoride varnish in preventing caries in adults is still not known clearly. Recommendations for topical fluoride use are based on expert opinion, extrapolating the evidence from permanent teeth of children and adolescents so very few studies exist in adults. Our study will be conducted to fill this critical gap in the use of fluoride varnish in adults particularly those at high risk of developing dental caries.Aim of the study is to find outthe effectiveness of fluoride varnish with oral health education vs oral health education in the prevention of caries among prisoners of Haryana.A 12-month randomized control trial with a parallel-group design will be conducted in the Jails of Haryana. The participants will be randomly divided into a control group and an experimental consisting of 200 participants each. In group 1 or the control group following recruitment, the participants will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail. Subsequent appointments will be scheduled at 1 month, 6 months until the end of the follow-up period. In the experimental group or Fluoride Varnish with Oral Health Education group,the participants will get oral health as outlined for Group 1 as well as professional application of 5% sodium fluoride varnish semi-annually. For oral health education, they will receive a questionnaire regarding knowledge attitude, and practice which will be followed by a standardized oral health education session of about 20 to 30 minutes. Posters and charts will be used for the same. Participants will be encouraged to ask questions. A tooth brushing demonstration will be done using a brushing model and a toothbrush. To reinforce this a poster will be displayed on the premises of the jail and Subsequent appointments will be scheduled at 1 month, 6 months until the end of the follow-up period. The dentist will use cotton to remove any extra saliva, clean, dry, and isolate the patient’s teeth using cotton rolls. Following that, using a disposable brush, the dentist will apply a 5% fluoride varnish to all of the patient’s tooth surfaces, and afterward, they will leave it on for one minute. The participants will be told to close their mouths to enable the varnish to dry out after application. They will be told not to brush until the following day and not to consume anything rough (abrasive) for the rest of the day. Oral Health related Quality of Life will be assessed using OHIP-14

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
35.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • A minimum of 3 years of sentence remaining.
  • 2.Age 35-50 years
  • Belonging to Male gender.

排除标准

  • Less than 20 teeth
  • with systemic conditions that directly increase the risk of caries 3.with less than three years remaining on their sentence as of the trial’s start date.

结局指标

主要结局

Net caries increments

时间窗: one year

Caries preventive fraction

时间窗: one year

knowledge, attitude, and practice

时间窗: one year

次要结局

  • oral hygiene status and oral hygiene knowledge(cost-effectiveness of implementing fluoride varnish application)

研究者

发起方
Dr Kanupriya Pandey
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kanupriya Pandey

Postgraduate Institute of Dental Sciences, Rohtak

研究点 (1)

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