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

Not Applicable

Completed

• Conditions: Early Childhood Caries; Dental Caries in Children

• 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

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