Effect of specifically designed dental mobile application on oral hygiene status and Streptococcus mutans levels in dental plaque of intellectually disabled children
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Improvement in oral hygiene status of the children included in the study
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 7.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Definitely negative children (FRANKL TYPE I) 2)Parent consent not obtained.
Outcomes
Primary Outcomes
Improvement in oral hygiene status of the children included in the study
Time Frame: 3 months, 6 months
Secondary Outcomes
- Decrease in the Streptococcus mutans levels in dental plaque samples of the children included in the study(3 months, 6 months)