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
Protocol serial number	RDO/90/12
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS National Programme for Primary Dental Care (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Barbara Chadwick
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
Email	ChadwickBL@cardiff.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Caries incidence 2. Acceptability of the techniques to parents and children 3. Cost effectiveness
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	16 Months
Upper age limit	66 Months
Sex	All
Target sample size at registration	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

Division of Dental Health and Development

Cardiff
CF4 4XY
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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