Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
20/09/2010
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 Barbara Chadwick

ORCID ID

Contact details

Division of Dental Health and Development
University of Wales College of Medicine
Heath Park
Cardiff
CF4 4XY
United Kingdom
+44 (0)1222 7454090
ChadwickBL@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDO/90/12

Study information

Scientific title

Acronym

Study hypothesis

A randomised control trial to determine the effectiveness of glass ionomer sealants in pre-school children as a preventative measure designed to reduce the incidence of dental caries. The outcomes of this trial are:
1. Reduction of dental caries in pre-school children at high risk of disease by the use of glass ionomer sealants as a preventative measure.
2. Evidence of the cariostatic effect of glass ionomer sealants placed as fissure sealants in the primary dentition, a potentially cost effective technique.

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

Dental caries

Intervention

Added 27/08/10:
All children (n = 508) received a standard package of dental health education. Children in the test group (n = 241) had their first primary molars sealed with glass ionomer. All the children were re-examined once at varying intervals between 12 and 30 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Caries incidence
2. Acceptability of the techniques to parents and children
3. Cost effectiveness

Secondary outcome measures

Not provided at time of registration

Overall trial start date

02/01/1999

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Infants and children 18 to 66 months in areas with high levels of disease (decayed, missing and filled teeth [dmft] status is 2.5 at five years) in South Wales.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

508

Participant exclusion criteria

Children over 66 months.

Recruitment start date

02/01/1999

Recruitment end date

01/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Dental Health and Development
Cardiff
CF4 4XY
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

1. 2005 main results in http://www.ncbi.nlm.nih.gov/pubmed/15591732
2. 2005 results on difficulties of patient recruitment in http://www.ncbi.nlm.nih.gov/pubmed/15854116

Publication citations

  1. Main results

    Chadwick BL, Treasure ET, Playle RA, A randomised controlled trial to determine the effectiveness of glass ionomer sealants in pre-school children., Caries Res., 39, 1, 34-40, doi: 10.1159/000081654.

  2. Results on difficulties of patient recruitment

    Chadwick BL, Treasure ET, Primary care research: difficulties recruiting preschool children to clinical trials., Int J Paediatr Dent, 2005, 15, 3, 197-204, doi: 10.1111/j.1365-263X.2005.00634.x.

Additional files

Editorial Notes