Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children:

NCT06381700 | Not Yet Recruiting

• 1 other identifier: DF CO2405/0014 (P)
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Is the MySmile app easy to use by secondary school children?
4. 4.Is the MySmile app acceptable to use from the perspective of secondary school children?

Conditions

Oral Disease; Gingival Diseases

Keywords

Mobile apps; Prevention; Oral Health Promotion; Schoolchildren

Outcome Measures

Primary Outcomes (2)

• The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972

  The mean decrement in plaque score from baseline to follow-up between the intervention and control group will be assessed. For this test, the plaque is disclosed using a two-tone disclosing agent. The great advantage of the two-tone effect is that it can differentiate a new and matured plaque. The presence (+) or absence (-) of plaque is recorded in a chart, and the plaque incidence in the oral cavity will be expressed as a percentage (%). To determine the plaque index of an individual, the total number of surfaces with plaque will be divided into the number of available surfaces times by 100. The mean decrement score is obtained by subtracting the mean score at follow-up from the mean score at baseline. Finally, the mean decrement scores of the intervention and control groups are compared.

  after 4 weeks and 12 weeks post-intervention

• The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963

  For the selection of tooth, six (6) index teeth will be used. Each tooth will be assessed by scoring 0 = normal gingiva, 1 = Mild inflammation- a slight change in colour and slight oedema. No bleeding on probing, 2 = Moderate inflammation. Redness, oedema and glazing. Bleeding on probing, 3 = Severe inflammation, marked redness and ulceration and tendency toward spontaneous bleeding. To calculate the index tooth score, the score for each four (4) scoring unit is summed up and divided into 4. To calculate the Gingival Index for the entire assessment, sum up the scores for all index teeth and then divide by six (total index teeth). This will provide an overall index score for the patient's gingival health. The mean increment score is obtained by subtracting the mean score at follow-up from the mean score at baseline. Finally, the mean increment scores of the intervention and control groups are compared.

  after 4 weeks and 12 weeks post-intervention

Secondary Outcomes (1)

• The mean increment of oral health knowledge, attitude and practice using validated questionnaires.

  after 4 weeks and 12 weeks post-intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will get the School Dental Service and MySmile App.

Other: MySmile app

Control Group

ACTIVE COMPARATOR

Participants in this group will get the School Dental Service only

Other: Control

Interventions

MySmile app OTHER

The MySmile app contains several features: A) Knowledge Hub 1. "Do You Know" section: This section consists of seven (7) topics where users can learn about oral health knowledge. 2. "Quiz time" section: In this section, school children can play games and challenge themselves. B) Track yourself Brushing diary Diet diary C) Get help 1. Ask an expert 2. Find your dentist 3. Friendly reminders

Intervention Group

Control OTHER

This will receive the usual School Dental Service. School Dental Service provide students who need dental treatment and will be called to be given treatment. Among the treatments given include: * Dental filling * Full mouth scaling * Dental extraction * Preventive treatment, such as topical fluoride application All treatment is free of charge except for dentures, crown/bridge work and orthodontics. Treatment for school children is based on normative needs assessment as determined by the dentist. A child is defined as orally fit when all required treatment in the SDS has been completed and appropriate oral hygiene status is maintained.

Control Group

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Muhammad Hamidie bin Saari

Kuala Lumpur, Wilayah Persukutuan Kuala Lumpur, 50480, Malaysia

Location

MeSH Terms

Conditions

Mouth Diseases; Gingival Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Periodontal Diseases

Study Officials

• Zamros Yuzadi Mohd Yusof, PHD

  Faculty of Dentistry, Universiti Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Hamidie Saari, Master

CONTACT

0176312109; meedie89@gmail.com

Zamros Yuzadi Mohd Yusof

CONTACT

03-79674805; zamros@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 24, 2024
• Study Start: March 1, 2025
• Primary Completion: June 17, 2025
• Study Completion: August 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)