Clinical trial NCT06381700: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children:
Official title: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: A Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oral Disease
Gingival Diseases
Keywords: Mobile apps
Prevention
Oral Health Promotion
Schoolchildren
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 303
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:

1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?
2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?
3. Is the MySmile app easy to use by secondary school children?
4. Is the MySmile app acceptable to use from the perspective of secondary school children?

Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours.

Detailed description: The selection of schools into the study will involve three (3) sampling levels. At the first level, acknowledging the division of secondary schools in the district into urban and rural, one matched-pair will be randomly selected from urban area, and another matched pair will be randomly selected from rural area. At the second level, randomisation of the school is carried out. The 2 schools in each of the matched-pair will be randomly allocated to intervention and control group. At the third level, six (6) classrooms from moderate academic performance level will be selected (2 classrooms from Form 3, Form 4, and Form 5, respectively). Students who fulfil the inclusion criteria will be invited to participate in the study. The randomisation sequence will be carried out by the statistician at the Faculty of Dentistry, Universiti Malaya

Eligibility criteria: 1. Inclusion criteria for school

   * Government-funded secondary school
   * Received SDS from the mobile dental squad/school dental clinic at least once a year.
   * High-risk schools with all indicators not meeting the district's benchmark.
2. Inclusion criteria for the participants:

   * Secondary school children aged 15-17 years old.
   * Medium to high dental plaque level - Plaque score more than 50%
   * Healthy with no chronic medical history and physical disabilities
   * Understand the English language.
   * Own a smartphone// have access to an Android-based smartphone

Primary outcomes:
measure: The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972
timeFrame: after 4 weeks and 12 weeks post-intervention
measure: The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963
timeFrame: after 4 weeks and 12 weeks post-intervention
Secondary outcomes:
measure: The mean increment of oral health knowledge, attitude and practice using validated questionnaires.
timeFrame: after 4 weeks and 12 weeks post-intervention.
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Muhammad Hamidie bin Saari
state: Wilayah Persukutuan Kuala Lumpur
Study officials:
affiliation: Faculty of Dentistry, Universiti Malaya
name: Zamros Yuzadi Mohd Yusof, PHD
role: PRINCIPAL_INVESTIGATOR
References: