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Not yet recruitingNCT07115433Updated Aug 11, 2025

Effectiveness of School-based Oral Health Intervention for Children

An interventional study of School-Based Oral Health Promotion Program in Oral and Health, sponsored by Universiti Putra Malaysia. Not yet recruiting at 3 sites in Pakistan. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oral
  • Health
03

In context

Lead sponsor

Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Children with systemic conditions affecting oral health
  • Those currently in other oral health interventions
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • No intervention
    Control group

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

  • Experimental
    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.

    Behavioral: School-Based Oral Health Promotion Program

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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

    Time frame: 6-months

  3. 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

    Time frame: 6 months

Secondary outcomes

  1. oral health practices

    Oral 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.

    Time frame: 6 months

  2. Oral Health Impact Profile.

    Oral 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

    Time frame: 6 months

07

Study locations

3 sites
08

References and documents

Publications

  • 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.
  • 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. PubMed 34256752 ↗
  • 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. PubMed 35346148 ↗
  • 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. PubMed 34698662 ↗

Individual participant data

Plan to share: No — Only the study protocol, statistical plan, and results will be shared in publications in peer-reviewed journals

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07115433
Lead sponsor
Universiti Putra Malaysia
Responsible party
Arshed Muhammad (PhD, Universiti Putra Malaysia) — Principal investigator
First posted
Aug 11, 2025
Start date
Aug 5, 2025 (estimated)
Primary completion
Feb 5, 2026 (estimated)
Completion
Feb 10, 2026 (estimated)
Last update
Aug 11, 2025

Study contacts

Dr. Mehwish Raheem, MBBS, MPH
Contact
kiranmehwish47@gmail.com
00923249479263
Muhammad Arshed, MBBS, MPH,PhD
Contact
drarshedchaudhary@gmail.com
00923137774464

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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