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临床试验/CTRI/2025/03/081666
CTRI/2025/03/081666尚未招募3 期

Comparative evaluation of Diet o gram vs Diet diary in determining the status of untreated dental caries in children:: An educational intervantion study

Dr Aalla Anjali Keerthana1 个研究点 分布在 1 个国家目标入组 788 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
788
试验地点
1
主要终点
number of new caries teeth will be assesed using DMFT in relation with diet pattern

研究概览

简要总结

Dental caries is a multifactorial disease with diet being one of the contributing factors. Frequent consumption of easily fermentable carbohydrates is a prerequisite for the development of caries. Hence, dental caries is directly related to diet, as it is dependent on the presence of sugars. Thus, a detailed dietary assessment is seen as an appropriate intervention for dental teams, for patients identified to be at high risk of dental caries. Several tools, such as 24-h dietary recall (retrospective) and diet-diaries (prospective), have been recommended for dietary assessment in dental practice. However, low adherence is found to be a recognized downside of their use in dental settings. Hence a need for the development of more appropriate tool for dietary assessment that is patient-centered and compatible with modern lifestyles is necessary to know the incidence of dental caries like a mobile app in relation with the dietary patterns. Frequency of diet has huge impact on dental caries. Hence there is need to collect 24 hour diet chart for 7 days to know the child’s type of diet and  frequency. Hence there is need to know the impact of dietogram app and diary diary and to know influence on the untreated dental caries.

This study aims to analyze the performance of Diet o gram app versus diet diary for determining a child’s diet pattern and to know the correlation of diet on the status of untreated  dental caries by calculating the newly formed carious lesions.

It is an observational study with educational intervention carried out in schools of Nellore district. Informed consent was obtained from the parents of children who will be participating in study.

788 children in the age range of 6 -12 years will participate in this study. After recruitment, untreated dental caries is scored based on ICDAS II criteria at baseline. The participants will be divided into two groups by using a simple randomization technique. The group 1 utilizes the diet o gram app, while Group 2 utilizes a diet diary. Later, instructions will be given to the respective group on how to record the data in a mobile application and diet diary for one week.  Based on the baseline data, a presentation on oral health is given to all the children as well as to the parents, outlining the significance of diet and how it affects the development of dental caries individually using a pamphlet to the group using diet diary and with AV aids to the group using diet o gram app. Based on the baseline data the diet assessment will be carried out using the formula Dental health diet score = [Food score + Nutrient score – Sweet score] in the mobile app. Subsequently, all the children will receive specific instructions on how to improve and maintain good healthy diet patterns based on their scores every month for a year. After a year the status of untreated dental caries  is assessed again using ICDAS II criteria and compared  between two individual groups.

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
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children in the age range of 6-12 years.
  • 2.Children and parents who are willing to participate in the study.
  • Parents using smartphones .
  • 4.Children with untreated carious tooth.
  • 5.ICDAS II scores 0,1,2 are included.

排除标准

  • Children with special health care needs
  • Children who are not willing to participate in the study.

结局指标

主要结局

number of new caries teeth will be assesed using DMFT in relation with diet pattern

时间窗: 1st week and after 12 months

次要结局

  • Comparison of which diet recording assessment, i.e, diet o gram versus the diet diary is best in recording the diet patterns effectively & have to determine thus the correlation of diet & newly formed dental caries lesions(12 months)

研究者

发起方
Dr Aalla Anjali Keerthana
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aalla Anjali Keerthana

Narayana dental college and hospital

研究点 (1)

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