Condition category
Oral Health
Date applied
05/05/2011
Date assigned
17/06/2011
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Milsom

ORCID ID

Contact details

Victoria House
Holloway
Runcorn
Cheshire
Runcorn
WA7 4TH
United Kingdom
+44 (0)192 859 3733
keith.milsom@hsthpct.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PHI/03/C1/017 UK Clinical Research Network portfolio number: 4292

Study information

Scientific title

A 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

Acronym

Study hypothesis

There 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

Cumbria & Lancashire REC B approved on 13th December 2005, ethics ref: 05/Q1309/2

Study design

Cluster randomised two compartment parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dental caries in children

Intervention

The 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 type

Drug

Phase

Not Applicable

Drug names

Fluoride varnish

Primary outcome measures

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

1. 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 trial start date

20/02/2006

Overall trial end date

03/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80 schools, 2080 children

Participant exclusion criteria

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

Recruitment start date

20/02/2006

Recruitment end date

03/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Victoria House
Runcorn
WA7 4TH
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 161 275 6782
martin.tickle@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21921250

Publication citations

  1. Results

    Milsom KM, Blinkhorn AS, Walsh T, Worthington HV, Kearney-Mitchell P, Whitehead H, Tickle M, A cluster-randomized controlled trial: fluoride varnish in school children., J. Dent. Res., 2011, 90, 11, 1306-1311, doi: 10.1177/0022034511422063.

Additional files

Editorial Notes