Clinical trial NCT04923581: Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).
Official title: Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Early Childhood Caries
Keywords: MOST, behavioural intervention, early childhood caries
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2021-06-11
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A factorial trial following the Multiphase optimization Strategy (MOST)
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the plaque index scores of participating children
timeFrame: at baseline, 3 and 6 months
measure: Change in children's frequency of toothbrushing and use of fluoridated toothpaste
timeFrame: at baseline, 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University, Faculty of Dentistry
city: Alexandria
country: Egypt
facility: Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry
Study officials:
affiliation: Alexandria University, Faculty of Dentistry
name: Merna Ihab, B.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University, Faculty of Dentistry
name: Maha El Tantawi, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University, Faculty of Dentistry
name: Wafaa E. El Din, PhD
role: STUDY_DIRECTOR
References:
citation: Ihab M, El Din WE, Ammar N, Yassin R, El Tantawi M. Using mHealth to promote parents' brushing of preschool children's teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST). Trials. 2022 Jan 6;23(1):17. doi: 10.1186/s13063-021-05931-0.