Administrative information
Title {1} | The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial |
Trial registration {2a and 2b}. | ClinicalTrials.gov ID: NCT04339647 |
Protocol version {3} | 5 April 2020, 1st version. |
Funding {4} | Impact-oriented Interdisciplinary Research Grant (IIRG-035A-2019), University of Malaya |
Author details {5a} | Zamros Yuzadi Mohd Yusof 1,2 Nurul Hayati Anwar 1,2,3, Nor Azlida Mohd Nor 1,2, Mariani Md Nor4, Siti Ezaleila Mustafa5 1 Department of Community Oral Health and Clinical Prevention, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia. 2 Community Oral Health Research Group, Faculty of Dentistry, University of Malaya, Kuala Lumpur, Malaysia. 3 Oral health division, Perak Health Department, Malaysia. 4 Department of Educational Psychology & Counselling, Faculty of Education, University of Malaya, Kuala Lumpur, Malaysia. 5 Department of Media and Communication Studies, Faculty of Arts and Social Sciences, University of Malaya, Kuala Lumpur, Malaysia. ZYMY is the chief investigator and conceived the study. ZYMY and NAMN led the SIMSP proposal and protocol development. NHA, MMN and SE contributed to the study design and development of the proposal. ZYMY is the lead trial methodologist. NHA led the development of the SIMSP packages. ZYMY, MMN, NAMN and SE contributed towards the development of the intervention packages. NHA provided advice on recruitment strategies, participant information literature, and school and parental engagement strategies. ZYMY drafted the manuscript. All authors read and approved the final manuscript. |
Name and contact information for the trial sponsor {5b} | Trial Sponsor: University of Malaya. Sponsor’s Reference: IIRG-035A-2019. Contact name: Ainin Sulaiman. Address: Dean, Social Advancement and Happiness Research Cluster, Level 7, Research Management & Innovation Complex (RMIC), University of Malaya, 50603 Kuala Lumpur, MALAYSIA.Telephone: Tel: +603-7967 7802 / 7804 / 7809. Fax: +603-7967 7813. Email: researchcluster@um.edu.my |
Role of sponsor {5c} | This funding source has no role in the design of the trial and will not have any role during its execution, analyses, interpretation of data, or decision to submit results. |
Introduction
Background and rationale {6a}
Scientific hypothesis
Objectives {7}
Hypothesis (alternative)
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Teacher’s OHE booklet
Parent's oral health infographics
Caries risk assessment (CRA) form
Control
Implementation of the intervention
Phase 1: DT first visit to preschools in both groups
Phase 2: DT second visit to preschools and initiation of intervention
Phase 3: DT third visit to preschools
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
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Instructions on child home toothbrushing.
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The importance of reducing child’s daily sugar intake and practising healthy bottle-feeding pattern.
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Revision on the delivery of the OHE lessons in class
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Revision on children’s daily toothbrushing supervision at school.