Supervised Toothbrushing and Oral Health Education in Primary Schools in Saudi Arabia

NCT07091578 | Active Not Recruiting

• 2 other identifiers: LRS/DP-23/24-4099924/1240/IRB
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to assess the feasibility of implementing school-based oral health programmes including supervised toothbrushing and oral health education. The main questions it aims to answer are:

• Is it feasible to implement supervised toothbrushing and oral health education programmes in primary schools in Riyadh, Saudi Arabia?
• What are the facilitators and barriers to implementation regarding programme acceptance, participation of school staff, and adherence to the supervision guidelines?
• How do these programmes influence children's self-reported oral health status, risk behaviours, and quality of life during the study period?
• What is the effect of these programmes on dental caries incidence, plaque and gingival bleeding scores over a one-year follow-up? Participants will:
• Take part in either a supervised toothbrushing programme or an oral health education programme.
• Undergo dental examinations at baseline and after one year of follow-up to assess changes in dental caries, and plaque and gingival bleeding scores.

Conditions

Dental Caries

Keywords

Dental Caries; Children; Toothbrushing; Oral Health Education; Primary Schools

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing supervised toothbrushing and oral health education programmes based on qualitative interviews

  Feasibility will be assessed through semi-structured interviews conducted with school staff and dental professionals. The interviews will explore programme acceptability, staff engagement, adherence to toothbrushing supervision protocols, and perceived barriers and facilitators to implementation. Data will be thematically analysed to identify factors influencing the programme implemation.

  At the end of the academic year (approximately 9 to 12 months after programme initiation)

Secondary Outcomes (3)

• Change in dental caries prevalence using dmft score

  Baseline and one-year follow-up

• Change in plaque and gingival health using Modified Plaque and Bleeding Scores

  Baseline, 9 months, and 12 months after programme initiation

• Children's oral health status, behaviours, risk factors, quality of life, and socio-demographic factors using the WHO Oral Health Questionnaire for Children

  Baseline and one-year follow-up

Study Arms (2)

Supervised Toothbrushing

EXPERIMENTAL

Children participated in a daily supervised toothbrushing programme conducted in school and received monthly oral health educational sessions by trained teachers and the dental team.

Behavioral: Supervised toothbrushing

Oral Health Education

ACTIVE COMPARATOR

Children received oral health education sessions in the classrooms provided by trained teachers and the dental team.

Behavioral: Oral Health Education

Interventions

Supervised toothbrushing BEHAVIORAL

In supervised toothbrushing intervention, dental hygienists trained school staff, obtained consent forms, distributed the oral hygiene kits, and provided support and advice if needed. Teachers' training included guidelines for infection prevention and control, and toothbrushing in dry areas adapted from the Public Health England (PHD) toothbrushing programme toolkit. A dry toothbrushing model was employed. Toothbrushing sessions took place daily during regular school hours for one academic year. Each session lasted for approximately 10 minutes and occured after break time at 9:20 am. Oral hygiene kits that include soft toothbrushes and 1450ppm fluoridated toothpaste were disseminated every three months. Teachers and dental hygienists provided monthly oral health educational sessions to students during regular school time.

Supervised Toothbrushing

Oral Health Education BEHAVIORAL

In oral health education intervention, dental hygienists and school staff collaborated to educate students about oral health. Dental hygienists trained school staff to deliver this programme effectively and offer continued support and guidance to school staff during the programme implementation. An oral health education toolkit partly adapted from the PHE toothbrushing programme toolkit was provided to the school before the start of the programme. Educational materials including lectures, leaflets, and activities were dispensed monthly. Oral health education was conducted once a month during regular school hours in the classroom, and each session lasted for one hour. Students were provided with comprehensive knowledge about oral health, such as proper toothbrushing techniques, the importance of routine dental check-ups, and healthy nutrition. Moreover, toothbrushing kits that include soft toothbrushes and 1450ppm fluoridated toothpaste were distributed every three months.

Oral Health Education

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students aged 5 to 8 years are in the first grade of primary school.
• Students must be medically fit.
• Students who provide consent to participate in the study.
• Students for whom a parent/ legal guardian has signed the consent form.

You may not qualify if:

• Students with systemic disease or any medically compromised condition that hinders their participation in the programme.
• Students who refuse to provide consent to participate in the study.
• Students for whom a parent/ legal guardian has refused to sign the consent form.

Sponsors & Collaborators

• Fatimah Alshehri: lead
• King Saud University: collaborator

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

Location

Related Publications (22)

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MeSH Terms

Conditions

Dental Caries

Interventions

Health Education, Dental

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Dentistry; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study adopted a single-blinded approach, with an assessor blinded to the interventions. Blinding was implemented by maintaining a clear separation of roles. The dental professionals delivering interventions were not involved in outcome assessments, and outcome assessors did not have access to information about the specific interventions received by participants. Once schools had been assigned to intervention groups, students, school staff, and the dental professionals delivering interventions were blinded due to the nature of the intervention. However, outcome assessors responsible for conducting dental examinations were blinded to participants' assigned intervention groups to minimise potential bias. Dentists acted as outcome assessors and performed baseline and follow-up dental examinations, whereas dental hygienists oversaw the interventions, including supervised toothbrushing and oral health education.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study employed a pilot study with three parallel groups. The study was carried out in three public primary schools in Riyadh, Saudi Arabia, for one calendar year. Each school is assigned to either supervised toothbrushing or oral health education with a 1:1:1 allocation ratio. Students, school staff, and dental professionals were actively involved in this study. Students were engaged in oral health programmes throughout the academic year, enabling a thorough evaluation of the interventions' impact on their oral health. School staff and dental professionals conducted the interventions; their feedback will be valuable in identifying facilitators and barriers to the implementation. This design provides useful insights into the barriers and facilitators of delivering oral health programmes in primary schools, allowing for testing programme feasibility before conducting larger-scale implementation in the future (Eldridge and Kerry, 2012).

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: August 18, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)