Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2009
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

Prof Anthony Blinkhorn

ORCID ID

Contact details

Dept of Dental Health and Medicine
Dental School Higher
University of Manchester
Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 2756610

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes