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ISRCTN
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ISRCTN26422175
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ClinicalTrials.gov identifier
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Public title
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A clinical trial of the effectiveness of a dental caries prevention program for young children
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Scientific title
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Acronym
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N/A
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Serial number at source
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MCT-63155
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Ethics approval received from the McGill Faculty of Medicine Institutional Review Board on the 6th January 2003.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Early childhood caries
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Dyads will be excluded if parents are unable to understand the consent form and self-complete questionnaires for linguistic reasons
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Anticipated start date
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01/09/2003
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Anticipated end date
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31/05/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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821
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Interventions
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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
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Primary outcome measure(s)
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Number of decayed missing and filled tooth surfaces 24 months following recruitment.
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63155)
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Trial website
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Publications
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Contact name
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Dr
Paul John
Allison
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Address
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Faculty of Dentistry
McGill University
Rm 238D, Strathcona Building
3640, University St.
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City/town
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Montreal
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Zip/Postcode
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H3A 2B2
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Country
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Canada
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Tel
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+1 514 398 7203 (00045)
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Fax
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+1 514 398 8242
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Email
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paul.allison@mcgill.ca
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Sponsor
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McGill University (Canada)
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Address
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3640 University St.
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City/town
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Montreal
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Zip/Postcode
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H3A 2B2
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Country
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Canada
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Tel
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+1 514 398 7203 ext 00045
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Fax
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+1 514-398-3594
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Email
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paul.allison@mcgill.ca
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Date applied
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16/11/2005
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Last edited
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10/12/2007
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Date ISRCTN assigned
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16/11/2005
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