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

ISRCTN ISRCTN72589426
DOI https://doi.org/10.1186/ISRCTN72589426
Secondary identifying numbers PHI/03/C1/017 UK Clinical Research Network portfolio number: 4292
Submission date
05/05/2011
Registration date
17/06/2011
Last edited
29/10/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Tooth decay is a growing problem in children. The amount of children suffering from cavities (where an area of the tooth decays causing a hole) and requiring dental treatment (fillings) has risen dramatically in recent years. Many children have high amounts of sugar in their diets. The bacteria which are naturally present in the mouth use these sugars to produce acids, which damage the protective enamel on teeth over time, causing cavities. Cavities are most common in molars (back teeth) as they can be more difficult to keep clean when brushing teeth. Fluoride is a natural mineral in the diet, which helps to strengthen tooth enamel, protecting against tooth decay. Research has shown that applying fluoride varnish to teeth can help to stop and prevent tooth decay which leads to the development of cavities. The aim of this study is to find out whether fluoride varnish can help to prevent tooth decay in children.

Who can participate?
Children aged 7-8 who attend state schools in Northwest England (UK)

What does the study involve?
The included schools are randomly allocated into two groups. Children who attend schools in the first group have a fluoride varnish applied to their first permanent molars (back teeth), up to nine times over a three year period. Children who attend schools in the second group do not receive any additional treatment, and continue with their normal tooth care routines. Over the course of the study, the amount of children who need to have fillings is recorded in both groups.

What are the possible benefits and risks of participating?
Participants who receive the fluoride varnish treatment may develop fewer cavities as their teeth have a greater amount of protection than brushing alone. There no notable risks of taking part in the study, although the application of the fluoride varnish may be an inconvenience to some children.

Where is the study run from?
95 Local Authority primary schools in Northwest England (UK)

When is the study starting and how long is it expected to run for?
February 2006 to April 2009

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Professor Keith Milsom
keith.milsom@hsthpct.nhs.uk

Contact information

Prof Keith Milsom
Scientific

Victoria House
Holloway
Runcorn
Cheshire
Runcorn
WA7 4TH
United Kingdom

Phone +44 (0)192 859 3733
Email keith.milsom@hsthpct.nhs.uk

Study information

Study designCluster randomised two compartment parallel trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA cluster randomised controlled trial to measure the benefit of fluoride varnish preventing dental decay when applied to permanent teeth of children for 3 years in the school setting
Study objectivesThere is a difference in dental decay experience in posterior permanent teeth of children aged 9-11 years at outcome who have received up to nine applications of fluoride varnish when compared with children receiving no fluoride varnish.
Ethics approval(s)Cumbria & Lancashire REC B approved on 13th December 2005, ethics ref: 05/Q1309/2
Health condition(s) or problem(s) studiedDental caries in children
InterventionThe application of fluoride varnish on the occlusal surfaces of the first permanent molars up to nine times over a three year period.

The control group had no intervention.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Fluoride varnish
Primary outcome measureThe decayed, filled surfaces increment in first permanent molars on the intention-to-treat (ITT) population. The increment will be measured visually.
Secondary outcome measures1. The decayed, filled surfaces increment in deciduous molars on the ITT population. The increment will be measured visually.
2. A sub group analysis for the frequency of applications of the varnish
Overall study start date20/02/2006
Completion date03/04/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit7 Years
Upper age limit8 Years
SexBoth
Target number of participants80 schools, 2080 children
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment20/02/2006
Date of final enrolment03/04/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Victoria House
Runcorn
WA7 4TH
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone +44 161 275 6782
Email martin.tickle@manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Government

Department of Health (UK) - National Co-ordinating Centre for Research Capacity Development, Public Health Initiative (PHI/03/C1/017)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2011 Yes No