Tooth decay Oral Health
Conditions
Interventions
CHOICE is designed as a two-arm randomised controlled trial and aims to compare the clinical effectiveness and cost-effectiveness of the behavioural intervention DR-BNI in addition to usual care in 3-
however must be within 12 weeks of randomisation. During this visit, the parent/primary caregiver will learn about how to prevent further tooth decay in their child. The dental nurse will support pare
Sponsors
Queen's University Belfast
Eligibility
Sex/Gender
All
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/05/2025: 1. Child has caries experience: 1.1. At least one carious lesion into dentine, AND/OR 1.2. At least one restoration (filling) for treatment of caries, AND/OR 1.3. At least one extraction for treatment of caries 2. Aged =3 years and <8 years at the time of randomisation 3. Child is receiving NHS dental care 4. The intervention can be received in a comprehensible way by the child’s parent/primary caregiver 5. Written and informed consent obtained from the child’s parent/primary caregiver and agreement to comply with the requirements of the study 6. The child is reported by the parent as having at least one current oral health risk behaviour (confirmed at eligibility) Previous inclusion criteria: 1. Child has at least one carious lesion into dentine 2. Aged =3 years and <8 years at the time of randomisation 3. Child is receiving NHS dental care 4. The intervention can be received in a comprehensible way by the child’s parent/primary caregiver 5. Written and informed consent obtained from the child’s parent/primary caregiver and agreement to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/05/2025: Child is living in the same household as someone already recruited to the CHOICE Trial Previous exclusion criteria: 1. Child presents with advanced caries that require referral for extractions 2. Child presents with only arrested carious lesions into dentine in primary teeth [arrested as defined within national epidemiological criteria] 3. Child is living in the same household as someone already recruited to the CHOICE Trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/05/2025: Number of teeth which have caries experience (measured at dentinal level) at 24 months post-randomisation and were caries-free or unerupted at baseline, measured by dental assessment at Screening/Baseline and 24 months (+/- 3 months) Previous primary outcome measure: Caries experience (measured at dentinal level) at 24 months post-randomisation in any tooth which was caries-free or unerupted at baseline, measured by dental assessment at Screening/Baseline and 24 months (+/- 3 months) Added 07/08/2024: ENCOURAGE sub-study: 1. Salivary levels of lactic acid measured using salivary metabolomics at randomisation (baseline) and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/05/2025: 1. Parent-reported attitudes to child oral health behaviours (seven subscales) measured using Oral Health Behaviours and Regret/Relief Questionnaire at Screening/Baseline, 12 months (+/- 3 months, 24 months (+/- 3 months) 2. Parent-reported child oral health behaviours (four measures) measured using Oral Health Behaviours and Regret/Relief Questionnaire at Screening/Baseline, 12 months (+/- 3 months), 24 months (+/- 3 months) 3. Episodes of dental pain measured using dental pain data recorded from patient records by GDP at 12 months (+/- 3 months, 24 months (+/- 3 months) 4. Number of filled teeth (caries free or unerupted at baseline) at 24 months post-randomisation measured using dental treatment data recorded from patient records by GDP at 12 months (+/- 3 months, 24 months (+/- 3 months) 5. Number of extracted teeth (caries free or unerupted at baseline) 24 months post-randomisation measured using Dental treatment data recorded from patient records by GDP at 12 months (+/- 3 months, 24 months (+/- 3 months) Economic outcomes: 1. Health-related quality of life (EQ-5D-Y) measured using the EQ-5D-Y Proxy Questionnaire at screening/baseline, 12 months (+/- 3 months), 24 months (+/- 3 months) 2. Costs of treatment measured using Dental treatment data requested from the NHS at Study completion SWAT outcomes: 1. Attendance for a dental checkup measured using the number of attendees at screening/baseline 2. Recruitment into the CHOICE trial measured using the number of participants recruited at screening/baseline Qualitative outcomes: 1. Fidelity to the DR-BNI measured using Audio recordings of the CHOICE intervention at the CHOICE Intervention Visit 2. Number and type of goals chosen; behaviour techniques used measured using participants' goals and prescription for change at the CHOICE Intervention Visit 3. Facilitators and barriers to recruitment of the target population measured using Qualitative Interviews at 1 | — |
Countries
England, Northern Ireland, United Kingdom
Outcome results
None listed