Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).

Not Applicable

Completed

• Conditions: Early Childhood Caries; Dental Caries in Children
• Interventions: Behavioral: Oral Health Behavioral Interventions

• Registration Number: NCT04923581
• Lead Sponsor: Merna Ihab

Brief Summary

In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.

Detailed Description

The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2023-07-08
• Primary Completion: 2023-10-30
• Study Completion: 2023-11-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

• Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
• Mothers of children who are physically disabled or medically compromised.
• Mothers of children in need of emergency dental treatments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 1	Oral Health Behavioral Interventions	Participants will receive the constant component only.
Condition 3	Oral Health Behavioral Interventions	Participants will receive the constant component and oral health promotion messages.
Condition 8	Oral Health Behavioral Interventions	Participants will receive the constant component, motivational interview session, oral health promotion messages and storytelling videos
Condition 2	Oral Health Behavioral Interventions	Participants will receive the constant component and storytelling videos .
Condition 4	Oral Health Behavioral Interventions	Participants will receive the constant component, oral health promotion messages, and storytelling videos.
Condition 6	Oral Health Behavioral Interventions	Participants will receive the constant component, motivational interview session, and storytelling videos.
Condition 5	Oral Health Behavioral Interventions	Participants will receive the constant component and motivational interview session.
Condition 7	Oral Health Behavioral Interventions	Participants will receive the constant component, motivational interview session, and oral health promotion messages.

Primary Outcome Measures

Name	Time	Method
Change in the plaque index scores of participating children	at baseline, 3 and 6 months	Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene
Change in children's frequency of toothbrushing and use of fluoridated toothpaste	at baseline, 3 and 6 months	Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene

Trial Locations

Locations (2)

Alexandria University, Faculty of Dentistry; 🇪🇬 Alexandria, Egypt

Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry; 🇪🇬 Alexandria, Egypt