The Mancunian Fluoride Varnish Project

ISRCTN	ISRCTN22801431
DOI	https://doi.org/10.1186/ISRCTN22801431
Protocol serial number	N0353062296
Sponsor	Department of Health (UK)
Funder	Manchester Primary Care NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gill Davies
Scientific

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

Primary study design	Interventional
Study design	Randomised single blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Can fluoride varnish (Duraphat®) reduce dental caries among school children when used as a public health measure?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2004

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	664
Key inclusion criteria	Year 2 and Year 3 children in schools in South Manchester.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/06/2000
Date of final enrolment	01/09/2004

Central Manchester Primary Care NHS Trust

Manchester
M21 7RL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2007		Yes	No