Plain English Summary
Background and study aims
Tooth decay in the primary (milk) teeth is the most common disease in childhood. Once children develop tooth decay they very commonly suffer toothache and then often need to have their teeth extracted, all of which has a big effect on young children and their families. Tooth decay is preventable but recent research shows that preventative care provided by family dentists working in the NHS is unreliable and ineffective. This study evaluates the effects and costs of a simple ‘prevention package’ provided by family dentists to children aged 2-4 who are free of decay at the beginning of the study.
Who can participate?
Children aged 2 to 4 years attending selected General Dental Service practices/Community Dental Service clinics.
What does the study involve?
Once parents have agreed to let their children take part in the study, children are randomly allocated to one of two groups. One group get the prevention package twice a year over a 3-year period. The prevention package consists of three things: fluoride varnish painted on the teeth by the dentist, family-strength fluoride toothpaste and simple advice on how to prevent tooth decay. The other group only receive the simple advice on how to prevent tooth decay. All children attend their dentist at 6 monthly intervals. The study compares the numbers of children who develop tooth decay in each group over a 3-year period. The children receive a standardised dental examination at the start and end of the study by trained and calibrated dentists who are unconnected to the practices. The number of children who have toothache or have teeth extracted are also counted and compared. The costs to the NHS and to parents of providing the prevention package are measured and the costs of providing dental treatments such as fillings and extractions are assessed in both groups.
What are the possible benefits and risks of participating?
The varnish used in the study has been widely used across the world for many years and any side-effects to the varnish are extremely unlikely to occur and would be very mild if they do. In addition to fluoride, the varnish contains ethanol and a natural resin called colophony, which is found in sticking plasters. In highly exceptional circumstances, use of colophony has resulted in allergic reactions and for this reason we are excluding all children who have been hospitalised due to severe asthma or other allergic conditions. Another possible side effect is dental fluorosis which may occur and which affects adult teeth. In its mildest form dental fluorosis appears as fine white lines or flecking on the enamel surface of the teeth, which can often only be detected by a dental expert. This is unlikely because advice is given to parents on the use of fluoride toothpaste and the fluoride varnish is professionally applied according to guidance.
Where is the study run from?
University of Manchester and 22 dental practices in Northern Ireland (UK)
When is the study starting and how long is it expected to run for?
October 2009 to September 2015
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Prof. Martin Tickle
A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services
Whether a preventive package supplied to young children regularly attending general dental practice will be effective in keeping them free from dental caries.
Central Manchester Research Ethics Committee, 08/07/2009, ref: 09/H1008/93
Individually randomised two-compartment parallel-group phase IV pragmatic trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
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 toothbrush and standardised health education delivered by the dentist or hygienist.
Standardised health education delivered by the dentist or hygienist.
Primary outcome measure
The conversion of caries free children to caries active (caries into dentine) children, measured at baseline and at 36 months.
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of Manchester
Trial participating centre
22 dental practices in Northern Ireland
University of Manchester (UK)
+44 (0)161 275 8795
Belfast Health and Social Care Trust (UK)
King Edward Building
Royal Victoria Hospital Site
University of Manchester
Health Technology Assessment Programme
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21985746
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27685609
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28375708
2017 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/28521109
Tickle M, Milsom KM, Donaldson M, Killough S, O'Neill C, Crealey G, Sutton M, Noble S, Greer M, Worthington HV, Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) 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., BMC Oral Health, 2011, 11, 27, doi: 10.1186/1472-6831-11-27.