Effectiveness of School-based Oral Health Intervention for Children

Not Applicable

Not yet recruiting

• Conditions: Oral; Health

• Registration Number: NCT07115433
• Lead Sponsor: Universiti Putra Malaysia

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study Start: 2025-08-05
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-02-05
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral Hygiene	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.; 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 score	6 months	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
Plaque score	6 months	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.

Secondary Outcome Measures

Name	Time	Method
oral health practices	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.
Oral Health Impact Profile.	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; 1. = Hardly ever; 2. = Occasionally; 3. = Fairly often; 4. = Very often Greater score shows better impact andvice versa

Trial Locations

Locations (3)

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

Saleem ullah fahmi memorial school unit 1; 🇵🇰 Karachi, Pakistan

Saleem ullah fahmi school Khuda ki basti; 🇵🇰 Karachi, Pakistan