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Northern Ireland Caries Prevention In Practice trial

A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36180119
Enrollment
1200
Registered
2009-08-19
Start date
2011-04-13
Completion date
Unknown
Last updated
2017-07-03

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

Conditions

Dental caries Oral Health Dental caries

Interventions

Test Group: The application, by a dentist, twice a year, at approximately 6-monthly intervals and for 3 years, of 22600 ppm fluoride varnish and the supply, twice a year, of 1450 ppm toothpaste plus t

Sponsors

University of Manchester (UK)
Lead Sponsor
Belfast Health and Social Care Trust (UK)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 2 to 4 years, either sex 2. Attending selected General Dental Service practices/Community Dental Service clinics 3. Parent or legal guardian signs a Consent Form

Exclusion criteria

Exclusion criteria: 1. Children with caries into dentine 2. A past history of fillings or extractions due to caries 3. Children with fissure sealants on primary molar teeth 4. Children with history of severe allergic reactions requiring hospitalisation 5. Children already participating in any other clinical study at recruitment

Design outcomes

Primary

MeasureTime frame
The conversion of caries free children to caries active (caries into dentine) children, measured at baseline and at 36 months.

Secondary

MeasureTime frame
Assessed by parental questionnaires and site-based clinical data collection forms at 6-monthly intervals from 6 months through to 36 months: 1. The number of carious surfaces (caries into dentine in primary teeth) that develop in children who convert from caries free to caries active 2. The effect on direct and indirect costs

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026