A randomised controlled trial to determine the effectiveness of glass ionomer sealants in pre-school children
| ISRCTN | ISRCTN98615437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98615437 |
| Secondary identifying numbers | RDO/90/12 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 20/09/2010
- 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
Dr Barbara Chadwick
Scientific
Scientific
Division of Dental Health and Development
University of Wales College of Medicine
Heath Park
Cardiff
CF4 4XY
United Kingdom
| Phone | +44 (0)1222 7454090 |
|---|---|
| ChadwickBL@cardiff.ac.uk |
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 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 02/01/1999 |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 16 Months |
| Upper age limit | 66 Months |
| Sex | Both |
| Target number of participants | 508 |
| Key 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. |
| Key exclusion criteria | Children over 66 months. |
| Date of first enrolment | 02/01/1999 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Division of Dental Health and Development
Cardiff
CF4 4XY
United Kingdom
CF4 4XY
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
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 | main results | 01/01/2005 | Yes | No | |
| Results article | results on difficulties of patient recruitment | 01/05/2005 | Yes | No |
