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NCT Number: NCT07115433

Effectiveness of School-based Oral Health Intervention for Children

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.

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Key information

Conditions

Oral Health

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saleem ullah fahmi school baqai Medical complex gharo, Karachi, Sindh, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Plaque score

    Time frame: 6 months

    Plaque score index: 0: No plaque.

    • Separate flecks of plaque at the gum line.
    • A thin band of plaque along the gum line.
    • A band of plaque wider than 1mm but covering less than one-third of the tooth.
    • Plaque covering one-third to two-thirds of the tooth.
    • Plaque covering more than two-thirds of the tooth. Higher scores indicate more plaque and poorer oral hygiene.

  2. Oral Hygiene

    Time frame: 6-months

    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.

    • Debris or calculus covers less than one-third of the surface.
    • Debris or calculus covers between one-third and two-thirds of the surface.
    • 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

  3. Gingival score

    Time frame: 6 months

    Gingival score assessed by the gingival score index:

    0: Normal gingiva, no inflammation.

    • Mild inflammation - slight color change and edema (swelling), no bleeding on probing.
    • Moderate inflammation - redness, edema, glazing, and bleeding on probing.
    • 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 outcomes

  1. oral health practices

    Time frame: 6 months

    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.

  2. Oral Health Impact Profile.

    Time frame: 6 months

    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

    • = Hardly ever
    • = Occasionally
    • = Fairly often
    • = Very often Greater score shows better impact andvice versa

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Mehwish Raheem, MBBS, MPH

CONTACT

[email protected]

00923249479263

Muhammad Arshed, MBBS, MPH,PhD

CONTACT

[email protected]

00923137774464

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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