Contact information
Type
Scientific
Primary contact
Dr Paul John Allison
ORCID ID
Contact details
Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640
University St.
Montreal
H3A 2B2
Canada
+1 514 398 7203 (00045)
paul.allison@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-63155
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the McGill Faculty of Medicine Institutional Review Board on the 6th January 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2003
Overall trial end date
31/05/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
821
Participant exclusion criteria
Dyads will be excluded if parents are unable to understand the consent form and self-complete questionnaires for linguistic reasons
Recruitment start date
01/09/2003
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Canada
Trial participating centre
Faculty of Dentistry
Montreal
H3A 2B2
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63155)
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