To measure the benefit of fluoride varnish in preventing dental decay when applied to permanent teeth of children for 3 years in the school setting
- Conditions
- Dental caries in childrenOral HealthDental caries
- Registration Number
- ISRCTN72589426
- Lead Sponsor
- niversity of Manchester (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2080
1. Schools - all state maintained Local Authority primary schools in the study area. Participating schools must have formally agreed to take part int he study.
2. Children - Aged 7-8 years inclusive of children who attend Local Authority primary schools. Participants must have an informed consent form signed by a parent or legal guardian permitting participation of their child.
1. Presence of fixed orthodontic appliances involving more than four permanent teeth
2. Participation in any other clinical study during the three months preceding the initial examination
3. Subjects with a history of asthma that required hospitalisation
4. Subjects with a histroy of severe allergic reactions that required hospitalisation
5. Subjects experiencing ulcerative gingivitis or stomatitis
6. Subjects with a history of allergy to any of the ingredients in the test products
7. Subject is uncooperative/ unable to be examined
8. Children attending special schools
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The decayed, filled surfaces increment in first permanent molars on the intention-to-treat (ITT) population. The increment will be measured visually.
- Secondary Outcome Measures
Name Time Method 1. The decayed, filled surfaces increment in deciduous molars on the ITT population. The increment will be measured visually.<br>2. A sub group analysis for the frequency of applications of the varnish