orthern Ireland Caries Prevention In Practice trial
Completed
- Conditions
- Dental cariesOral Health
- Registration Number
- ISRCTN36180119
- Lead Sponsor
- niversity of Manchester (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The conversion of caries free children to caries active (caries into dentine) children, measured at baseline and at 36 months.
- Secondary Outcome Measures
Name Time Method Assessed by parental questionnaires and site-based clinical data collection forms at 6-monthly intervals from 6 months through to 36 months:<br>1. The number of carious surfaces (caries into dentine in primary teeth) that develop in children who convert from caries free to caries active<br>2. The effect on direct and indirect costs