An evaluation of a model system for active prevention in the general dental service.

ISRCTN	ISRCTN88646311
DOI	https://doi.org/10.1186/ISRCTN88646311
Secondary identifying numbers	RDO/90/19

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 08/12/2009

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

Not provided at time of registration

Contact information

Prof Anthony Blinkhorn
Scientific

Dept of Dental Health and Medicine
Dental School Higher
University of Manchester
Cambridge Street
Manchester
M15 6FH
United Kingdom

Phone	+44 (0)161 2756610

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title
Study objectives	A randomised, controlled trial will evaluate the benefit to child patients aged 2-5 years of a structured, practice-based dental health education package given to parents by dental health educators over a two year period. The null hypotheses tested will be: 1. The secondment of dental health educators to general dental practices will not influence the caries incidence of 'at risk' regularly attending pre-school child patients over a two year period. 2. There will be no cost-effective health gain from the use of dental health educators in the general practice setting. 3. The parents in the test group will not increase their knowledge on the prevention of caries more than those in the control group.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral health/stomatognathic diseases
Intervention	1. Control group children given a toothbrush and toothpaste and the parents will be interviewed and given instruction in the child's oral hygiene; they will be recalled at the end of two years, re-examined and the parents interviewed again. 2. Test group children will be given three dental health education visits at the beginning and one recall visit every 4 months for the two year study period. Children also given toothbrush and toothpaste and parents interviewed. The dental health education package will consist of detailed counselling on sugar control and the use of fluoride toothpaste for young children.
Intervention type	Other
Primary outcome measure	Incidence of caries
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1999
Completion date	31/10/2002

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	5 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Children 2-5 years
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/1999
Date of final enrolment	31/10/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept of Dental Health and Medicine

Manchester
M15 6FH
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS National Programme for Primary Dental Care (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/10/2003		Yes	No