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Effectiveness of School-based Oral Health Intervention for Children

Effectiveness of a School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07115433
Enrollment
600
Registered
2025-08-11
Start date
2025-08-05
Completion date
2026-02-10
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Oral

Brief summary

Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes. A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School Children for six months, while the control group will receive no intervention, only routine care.

Detailed description

Poor oral health in children leads to pain, absenteeism, and impaired quality of life. Schools provide an ideal setting for early interventions. Evidence suggests that educational programs incorporating behavioural change theories can improve oral hygiene practices and clinical outcomes. A School-Based Oral Health Promotion Program on Oral Health Practices, Behaviour, Self-Efficacy, and Clinical Outcomes Among Primary School. The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months, while the control group will receive no intervention, only routine care.

Interventions

BEHAVIORALSchool-Based Oral Health Promotion Program

Arm Description: The oral health promotion intervention will be implemented through weekly interactive sessions lasting 30-40 minutes over a period of six months. These sessions, conducted by trained dental educators and teachers, will use animations, storytelling, demonstrations, and role-plays to teach proper toothbrushing, the importance of fluoride toothpaste, healthy eating habits, and the need for regular dental visits. Children will participate in supervised toothbrushing once a week, supported by peer ambassadors who reinforce daily practices. Educational leaflets and videos will engage parents, while posters in classrooms serve as reminders. Follow-up assessments, including questionnaires and clinical indices, will be conducted at six months.

Sponsors

Universiti Putra Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigators and outcome assessors will be blinded

Intervention model description

It is two arm randomized control trial

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* Children aged 6-8 years enrolled in selected schools * Written informed consent from parents/guardians and assent from children

Exclusion criteria

* Children with systemic conditions affecting oral health * Those currently in other oral health interventions

Design outcomes

Primary

MeasureTime frameDescription
Plaque score6 monthsPlaque score index: 0: No plaque. 1. Separate flecks of plaque at the gum line. 2. A thin band of plaque along the gum line. 3. A band of plaque wider than 1mm but covering less than one-third of the tooth. 4. Plaque covering one-third to two-thirds of the tooth. 5. Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.
Oral Hygiene6-monthsOral Hygiene will be assessed by the presence of debris (plaque) and calculus (tartar) on selected tooth surfaces, measured by the Simplified Oral Hygiene Index (OHI-S) Individual Debris Index (DI-S) and Calculus Index (CI-S): Each of the six surfaces is scored individually for both debris and calculus using a 0-3 scale: 0: No debris or calculus is present. 1. Debris or calculus covers less than one-third of the surface. 2. Debris or calculus covers between one-third and two-thirds of the surface. 3. Debris or calculus covers more than two-thirds of the surface. Good: 0.0 - 1.2 Fair: 1.3 - 3.0 Poor: 3.1 - 6.0
Gingival score6 monthsGingival score assessed by the gingival score index: 0: Normal gingiva, no inflammation. 1. Mild inflammation - slight color change and edema (swelling), no bleeding on probing. 2. Moderate inflammation - redness, edema, glazing, and bleeding on probing. 3. Severe inflammation - marked redness, edema, ulceration, and tendency towards spontaneous bleeding. The index typically uses a scale of 0 to 3, with 0 representing normal gingiva and higher scores indicating increasing severity of inflammation

Secondary

MeasureTime frameDescription
oral health practices6 monthsOral health practices by using the WHO Child Oral Health Questionnaire: o assess children's oral health practices through a structured set of questions. These questionnaires typically cover knowledge, attitude, and practices related to oral hygiene, including frequency of brushing, use of fluoride toothpaste, and dental visits. The score is used to evaluate the overall oral health practices of the child, often categorized as good, fair, or poor.
Oral Health Impact Profile.6 monthsOral Health Impact Profile. The Oral Health Impact Profile (OHIP) is a questionnaire used to assess how oral health problems affect a person's daily life and well-being. The OHIP-14, a shorter version, is commonly used and focuses on 14 specific questions related to oral health impacts 0 = Never 1. = Hardly ever 2. = Occasionally 3. = Fairly often 4. = Very often Greater score shows better impact andvice versa

Countries

Pakistan

Contacts

Primary ContactDr. Mehwish Raheem, MBBS, MPH
kiranmehwish47@gmail.com00923249479263
Backup ContactMuhammad Arshed, MBBS, MPH,PhD
drarshedchaudhary@gmail.com00923137774464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026