A clinical trial of the effectiveness of a dental caries prevention program for young children

ISRCTN	ISRCTN26422175
DOI	https://doi.org/10.1186/ISRCTN26422175
Secondary identifying numbers	MCT-63155

Submission date: 16/11/2005
Registration date: 16/11/2005
Last edited: 10/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul John Allison
Scientific

Faculty of Dentistry
McGill University
Rm 238D, Strathcona Building
3640, University St.
Montreal
H3A 2B2
Canada

Phone	+1 514 398 7203 (00045)
Email	paul.allison@mcgill.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	The hypotheses are that at study completion: 1. Children of caregivers randomised to the intervention group will have a mean number of decayed, missing or filled tooth surfaces (dmfs) one less than that of children whose caregivers were randomised to the control group 2. The proportion of children of caregivers in the intervention group who are caries free will be 20% more than the proportion of children caries free in the control group
Ethics approval(s)	Ethics approval received from the McGill Faculty of Medicine Institutional Review Board on the 6th January 2003.
Health condition(s) or problem(s) studied	Early childhood caries
Intervention	The test intervention is an educational one delivered by dental hygienists to parents of infants when the latter are 6, 12, 18 and 24 months old. Each of the four sessions lasts approximately 15 minutes. The control group receive no intervention i.e. 'normal care'. Trial details received: 12 September 2005
Intervention type	Other
Primary outcome measure	Number of decayed missing and filled tooth surfaces 24 months following recruitment.
Secondary outcome measures	1. Percentage of children without dental caries 2. Parent caries-related knowledge 3. Parent caries-related behaviour 4. Oral health-related impacts/quality of life 5. Child weight 6. Financial costs
Overall study start date	01/09/2003
Completion date	31/05/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Months
Upper age limit	7 Months
Sex	Both
Target number of participants	821
Key inclusion criteria	1. Caregivers (parents) who have a child of five to seven months, either sex (inclusive), with whom they are attending the vaccination clinics of the study community health centre recruitment sites (CLSCs) and who live with that child for 50% or more of the time will be asked to participate 2. The subjects included are parent/infant dyads
Key exclusion criteria	Dyads will be excluded if parents are unable to understand the consent form and self-complete questionnaires for linguistic reasons
Date of first enrolment	01/09/2003
Date of final enrolment	31/05/2006

Locations

Countries of recruitment

Canada

Study participating centre

Faculty of Dentistry

Montreal
H3A 2B2
Canada

Sponsor information

McGill University (Canada)
Not defined

3640 University St.
Montreal
H3A 2B2
Canada

"ROR"	https://ror.org/01pxwe438

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63155)

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