Effectiveness of School-based Oral Health Intervention for Children

NCT07115433 | Not Yet Recruiting DMC

• 1 other identifier: BMU-BDC
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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.

Conditions

Oral; Health

Outcome Measures

Primary Outcomes (3)

• Plaque score

  Plaque 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.

  6 months

• Oral Hygiene

  Oral 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

  6-months

• Gingival score

  Gingival 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

  6 months

Secondary Outcomes (2)

• oral health practices

  6 months

• Oral Health Impact Profile.

  6 months

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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.

Behavioral: School-Based Oral Health Promotion Program

Interventions

School-Based Oral Health Promotion Program 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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (3)

Saleem ullah fahmi school baqai Medical complex gharo

Karachi, Sindh, 74600, Pakistan

Location

Saleem ullah fahmi memorial school unit 1

Karachi, 74600, Pakistan

Location

Saleem ullah fahmi school Khuda ki basti

Karachi, 74600, Pakistan

Location

Related Publications (4)

• 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.

  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.

  PMID: 34256752 BACKGROUND

• 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.

  PMID: 35346148 BACKGROUND

• 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.

  PMID: 34698662 BACKGROUND

Central Study Contacts

Dr. Mehwish Raheem, MBBS, MPH

CONTACT

00923249479263; kiranmehwish47@gmail.com

Muhammad Arshed, MBBS, MPH,PhD

CONTACT

00923137774464; drarshedchaudhary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will be blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: It is two arm randomized control trial

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: August 5, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 10, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)