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Completed

NCT Number: NCT04923581

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

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.

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Key information

Conditions

Dental Caries in Children Early Childhood Caries

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of Dentistry, Alexandria, Egypt

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Health Behavioral Interventions

Behavioral

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.

Primary outcomes

  1. Change in the plaque index scores of participating children

    Time frame: at baseline, 3 and 6 months

    Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene

  2. Change in children's frequency of toothbrushing and use of fluoridated toothpaste

    Time frame: at baseline, 3 and 6 months

    Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene

Sponsors and collaborators

Lead sponsor

Merna Ihab

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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