Trial Design |
Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) is an individually randomised, two-compartment, parallel group phase IV pragmatic trial. Children will be randomised 1:1 into two groups. |
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Study Aim |
To measure the costs and effects of a ‘preventive package’ in keeping young children who regularly attend primary care service free of dental caries, compared with standard health education alone. The preventive package comprised of:
- Fluoride varnish containing 22,600 ppm fluoride applied twice a year
- A toothbrush provided twice a year
- Standardised, evidence based, dental health education provided twice a year.
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Objective 1: To compare over a 3 year period the effectiveness of 22.600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardized health education, provided twice a year, as a preventive package, with standardised health education alone provided twice a year in:
- Preventing the conversion of children from caries-free to caries-active states in the primary dentition
- Reducing the number of carious surfaces (caries into dentine) in the primary dentition in children who convert from caries free to caries active states
- Preventing episodes of pain and extraction of primary teeth in 2 and 3 year old children who are caries free at baseline and who attend primary care dentalservices
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Objective 2: To compare over a 3 year period the costs of dental care in a group receiving 22,600 ppm fluoride vcarnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year as a preventive package with a group receiving standardised heatlh education alone provided twice a year, in 2 and 3 year old children who are caries free at baseline and who attend primary care dental services. |
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