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A school-based study, co-designed with teachers and families to help improve children's oral health behaviours

BEE Smiley: a cluster-randomised trial to evaluate the effects of a co-designed, multi-component, school-based behavioural intervention to improve oral health behaviours

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73613884
Enrollment
306
Registered
2025-10-08
Start date
2025-09-17
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health behaviours (plaque control, toothbrushing habits, and sugar intake) Oral Health

Interventions

Randomisation will be at the cluster (school) level. A computer-generated randomisation schedule will be used to randomise eligible and consenting schools to the intervention or comparator groups (STA
educational materials based around COM-B for the family unit 2. Provision of self-care resources: toothbrush and toothpaste pack every 3 months with plaque disclosing tablet. In line with DBOH recomm

Sponsors

University of Manchester
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 8 Years

Inclusion criteria

Inclusion criteria: School inclusion criteria: 1. Provide written consent to participate in the study 2. Implement the allocated trial arm 3. Agree to provide space for the trial clinical assessment at baseline, 3 months, on school premises Child inclusion criteria: Children aged 7 to 8 years at the time of recruitment

Exclusion criteria

Exclusion criteria: Child exclusion criteria: 1. With hypersensitivity to Sodium Fluoride and/or other ingredients used in toothpaste or in the disclosing solution/ tablet used for the clinical assessment 2. Who have participated in any other clinical study during the 3 months preceding the initial examination 3. With the presence of ulcerative gingivitis/stomatitis

Design outcomes

Primary

MeasureTime frame
Plaque score at 3 months as indicated by PCR value from index teeth from the clinical assessment conducted by members of the CDS/dental hygiene/therapists. The primary outcome will be extracted from the Case Report Form completed by a member of the CDS/dental hygiene/therapists. This outcome will indicate whether improved oral hygiene behaviours have occurred over a relatively short period of time.

Secondary

MeasureTime frame
1. Self-reported secondary outcomes of habit formation in relation to behaviour change using items based on the ‘Self-reported behavioural automaticity index’ and Oral Health Activities Questionnaire will be taken at baseline, 3 months, and 6 months through questionnaires administered on an e-tablet (children will be supported to complete the questionnaire by the research team, CRN, or teachers). 2. Parental self-reported toothbrushing behaviour and habit formation will be collected online or by post at the parent/caregiver’s preference through the Brushing Behaviour Questionnaire, Toothbrushing Habit Formation Questionnaire and Brief Oral Health Survey at baseline, 3 months and 6 months. 3. School-level outcomes will include a process evaluation (fidelity to the intervention, context, and support of the intervention), and the acceptability and value of different components will be explored through qualitative analysis (qualitative interviews) at 6 months.

Countries

England, United Kingdom

Contacts

Public ContactNicola Boothman
nicola.boothman@manchester.ac.uk+44 (0)161 226 1211

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026