A Digital Intervention to Improve Oral Health Practices

Not Applicable

Not yet recruiting

• Conditions: Digital Intervention; Oral Health Behavior Change

• Registration Number: NCT07139561
• Lead Sponsor: Universiti Putra Malaysia

Brief Summary

This study evaluates a 16-week parent-focused digital intervention to improve oral health practices in children aged 6-10 through daily reminders, quizzes, challenges, gamification, and behavior tracking, supported by an optional moderated WhatsApp group for peer engagement and motivation.

Detailed Description

The intervention includes daily reminders with two brushing cues and one snack tip to reinforce habits. Weekly quizzes with 3-5 questions assess knowledge, while photo/video tasks such as "Show your foam smile" or "Healthy lunchbox challenge" keep engagement high. Gamification features badges for streaks like a 7-day brushing badge or snack swap champion. Parents track brushing, flossing, and snack swaps via a 1-tap tracker, supported by an optional moderated WhatsApp group.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study Start: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Parents or primary caregivers of children aged 6-10 years.
• Child must be free from major systemic illnesses or developmental disabilities that could interfere with oral hygiene practices.
• Parent/caregiver owns a smartphone with access to WhatsApp or similar digital platform.
• Ability to read or understand Urdu or English instructions.
• Willingness to participate for the full 12-week duration and provide informed consent.

Exclusion Criteria

• Children with serious medical conditions (e.g., immunodeficiency, congenital anomalies) that may affect oral health.
• Parents or children currently enrolled in another oral health education or digital intervention program.
• Children who have received professional oral health education or structured interventions within the past 4 months.
• Parents/caregivers unwilling or unable to comply with digital reporting and participation requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral health practices	4-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 Hygiene	4-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

Secondary Outcome Measures

Name	Time	Method
Plaque score	4-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	4-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

Trial Locations

Locations (4)

White house grammar School; 🇵🇰 Khānpur, Punjab, Pakistan

Baqai Medical complex school; 🇵🇰 Karachi, Sindh, Pakistan

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

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