Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gill Davies

ORCID ID

Contact details

Central Manchester Primary Care NHS Trust
Mauldeth House
Mauldeth Road West
Chorlton
Manchester
M21 7RL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0353062296

Study information

Scientific title

Acronym

Study hypothesis

Can fluoride varnish (Duraphat®) reduce dental caries among school children when used as a public health measure?

Ethics approval

Not provided at time of registration

Study design

Randomised single blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Oral Health: Cariology

Intervention

Quantitative: Cluster randomised controlled trial in 20 sites with a single blindness.
The children in 'test' received applications of fluoride varnish twice yearly, provided by dental therapists using mobile equipment in schools. The 'control' children received no fluoride varnish. All children were given paste and brushes at the time of baseline and 26 month examinations.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To measure the effects of fluoride varnish, applied twice yearly for 2 years, in schools, on the incidence of new carious lesions and control of existing lesions in the primary and permanent dentition.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Year 2 and Year 3 children in schools in South Manchester.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

334 test subjects, 330 controls

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/2000

Recruitment end date

01/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester Primary Care NHS Trust
Manchester
M21 7RL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Manchester Primary Care NHS Trust (UK)

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17713337

Publication citations

  1. Results

    Hardman MC, Davies GM, Duxbury JT, Davies RM, A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children., Caries Res., 2007, 41, 5, 371-376, doi: 10.1159/000104795.

Additional files

Editorial Notes