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
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
-
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.
-
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.