Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RDO/90/19
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of caries
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
31/10/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Children 2-5 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1999
Recruitment end date
31/10/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Dental Health and Medicine
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS National Programme for Primary Dental Care (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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14551632
Publication citations
-
Results
Blinkhorn AS, Gratrix D, Holloway PJ, Wainwright-Stringer YM, Ward SJ, Worthington HV, A cluster randomised, controlled trial of the value of dental health educators in general dental practice., Br Dent J, 2003, 195, 7, 395-400; discussion 385, doi: 10.1038/sj.bdj.4810566.