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临床试验/CTRI/2020/11/028862
CTRI/2020/11/028862尚未招募1 期

Effect of specifically designed dental mobile application on oral hygiene status and Streptococcus mutans levels in dental plaque of intellectually disabled children

Aayushi Sangal1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年12月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Improvement in oral hygiene status of the children included in the study

研究概览

简要总结

AIM: To evaluate the effect of a specifically designed dental mobile application on the oral hygiene status and Streptococcus mutans levels in dental plaque of intellectually disabled children. OBJECTIVES: To evaluate the improvement in oral hygiene status of intellectually disabled children after using the dental mobile application and to assess the Streptococcus mutans in dental plaque of intellectually disabled children at baseline and following the use of the dental mobile application at 3 months and 6 months. STUDY DESIGN: 90 intellectually disabled children (30 in each group - autistic, learning disabled and attention deficit hyperactivity disorder) in the age group of 7-18 years will be selected from the special schools of National Capital Region of India from where permission will be obtained and will be included in this study. Baseline evaluation of oral hygiene status and dental plaque sampling for assessment of Streptococcus mutans count will be done. Oral hygiene instructions will be delivered to them via video demonstrations in simple language through a specifically designed dental mobile application for them. Their caregivers will be instructed to show them the video everyday in the morning and at night before bedtime for 6 months. Oral hygiene status of these children as well as Streptococcus mutans levels in their dental plaque samples will be re-evaluated at 3 months and 6 months and the results will be subjected to statistical analysis. EXPECTED OUTCOMES: Improvement in the oral hygiene status and decrease in the Streptococcus mutans levels in dental plaque of intellectually disabled children after using the mobile application for 3 months and 6 months.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
7.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Age group of 7-18yrs.
  • Cooperative intellectually disabled children 3)Intellectual disabilities included are : a.Learning Disabled (LD) b.Autism Spectrum Disorder (ASD) c.Attention Deficit Hyperactive Disorder (ADHD) 4)DMFT/deft score of 2 and above.

排除标准

  • Definitely negative children (FRANKL TYPE I) 2)Parent consent not obtained.

结局指标

主要结局

Improvement in oral hygiene status of the children included in the study

时间窗: 3 months, 6 months

次要结局

  • Decrease in the Streptococcus mutans levels in dental plaque samples of the children included in the study(3 months, 6 months)

研究者

发起方
Aayushi Sangal
申办方类型
Other [self]

研究点 (1)

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