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

Dental Caries in Children Clinical Trial

Official title:

Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923581
• Other study ID #: MOST2021
• Status: Completed
• Phase: N/A
• Start date: July 8, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria for mother's of children enrolled in study:

• Has children between 2 and <5 years of age

• Has children with high plaque index scores (PlI=2 or visible plaque accumulation on maxillary anterior teeth).

• Literate and owns a mobile phone with already set-up or possibility to set-up Whats-App messenger application.

• Willing to participate in the study and receive periodic OHPm and ST videos.

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Early Childhood Caries

Intervention

Behavioral:
• Oral Health Behavioral Interventions
The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of Dentistry	Alexandria
Egypt	Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Merna Ihab	Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

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