Effectiveness of School-based Oral Health Intervention for Children

NCT ID: NCT07115433

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-02-10

Brief Summary

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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

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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.

Conditions

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Oral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is two arm randomized control trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigators and outcome assessors will be blinded

Study Groups

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Control group

The control group will be given no intervention other than they will receive routinely

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

School-Based Oral Health Promotion Program

Intervention Type BEHAVIORAL

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.

Interventions

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School-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Arshed Muhammad

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saleem ullah fahmi school baqai Medical complex gharo

Karachi, Sindh, Pakistan

Site Status

Saleem ullah fahmi memorial school unit 1

Karachi, , Pakistan

Site Status

Saleem ullah fahmi school Khuda ki basti

Karachi, , Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Dr. Mehwish Raheem, MBBS, MPH

Role: CONTACT

00923249479263

Muhammad Arshed, MBBS, MPH,PhD

Role: CONTACT

00923137774464

Facility Contacts

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Samreen Z Instructor, BDS

Role: primary

03150228348

Muhammad Raashed, DVM

Role: backup

03337474991

Mehwish banu, BDS

Role: primary

03323404875

Muhammad Arshed, MBBS, PhD

Role: backup

03337474464

Samreen Instructor, BDS

Role: primary

+92 332 2536389

Muhammad Arshed, MBBS, PhD

Role: backup

03337474464

References

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nsari Moghaddam S, Shahrzad S, Kermansaravi F. Effect of teach-back method on oral health indicators, self-efficacy, and self-care behaviors of high school students in Zahedan during 2019. J Mashhad Dent School. 2020;44(2):99-113.

Reference Type BACKGROUND

Hashemi ZS, Khorsandi M, Shamsi M, Moradzadeh R. Effect combined learning on oral health self-efficacy and self-care behaviors of students: a randomized controlled trial. BMC Oral Health. 2021 Jul 13;21(1):342. doi: 10.1186/s12903-021-01693-y.

Reference Type BACKGROUND
PMID: 34256752 (View on PubMed)

Sanaeinasab H, Saffari M, Taghavi H, Karimi Zarchi A, Rahmati F, Al Zaben F, Koenig HG. An educational intervention using the health belief model for improvement of oral health behavior in grade-schoolers: a randomized controlled trial. BMC Oral Health. 2022 Mar 27;22(1):94. doi: 10.1186/s12903-022-02132-2.

Reference Type BACKGROUND
PMID: 35346148 (View on PubMed)

Hernandez-Vasquez A, Azanedo D. The urgency of ensuring equitable and improved access to oral health care during the Coronavirus Disease 2019 pandemic: The case of Peru. J Res Health Sci. 2021 Aug 28;21(3):e00528. doi: 10.34172/jrhs.2021.60.

Reference Type BACKGROUND
PMID: 34698662 (View on PubMed)

Other Identifiers

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BMU-BDC

Identifier Type: -

Identifier Source: org_study_id

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