Welcome
Support Centre
01 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Dental caries prevention program for Cree mothers and infants
ISRCTN ISRCTN41467632
DOI 10.1186/ISRCTN41467632
ClinicalTrials.gov identifier
EudraCT number
Public title Dental caries prevention program for Cree mothers and infants
Scientific title A clinical trial of the effectiveness of a dental caries prevention program for Cree mothers and their infants
Acronym CreeC
Serial number at source MCT-67817
Study hypothesis Primary question:
Is there any difference in the dental health status of young Cree children whose mothers have participated in a client-centred, one-on-one, preventive counseling intervention, motivational interviewing (MI), and children whose mothers received oral health information in the form of an educational pamphlet? This question will be answered by testing the hypothesis that the prevalence of caries in 30 month old children will be lower in the experimental communities than in the control communities.

Secondary questions:
Are Cree motherís knowledge and beliefs about child dental health issues, their dental health practices, and child feeding and comforting practices altered by participation in a series of motivational interviewing (MI) interventions? This question will be answered by testing the null hypothesis that there will be no difference between the two groups of mothers.
Lay summary Not provided at time of registration
Ethics approval University of British Columbia (UBC) Behavioural Research Ethics Board (ref: Certificate B04-0295) - this is re-approved annually.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Early childhood caries or tooth decay
Participants - inclusion criteria 1. 309 Cree mother-child pairs in Eeyou Istchee (Cree territory of northern Quebec)
2. Mothers aged 18 - 49 years old
Participants - exclusion criteria Any pregnant women or woman with a newborn who knows that she will be imminently moving out of the Cree territory.
Anticipated start date 01/04/2004
Anticipated end date 31/03/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 309
Interventions Primary intervention is behavioural: motivational interviewing (MI)
Experimental group: The first MI session will occur during pregnancy at time of enrolment. Mothers will participate in at least five more MI sessions that will correspond with well-child immunisation visits between two and 24 months of age. Fluoride varnish will be offered at the 12, 18 and 24 month visits.

Control group: Mothers will receive a pamphlet. Fluoride varnish will be available at local dental clinics.
Primary outcome measure(s) The prevalence of caries, or percentage of 30 month old children with decayed, extracted and filled surfaces (DEFS) more than zero, in each community will be determined. A childís experience of caries will be determined by recording the DEFS, or number of decayed, extracted or filled primary tooth surfaces.
Secondary outcome measure(s) Data on dental health knowledge, oral home care practices, child-feeding and comforting practices will be collected at 30 months and compared between test and control communities. In addition, data on "caries-related health impacts", for example, history of pain, food avoidance or poor sleeping as a result of dental pain, and dental treatment received as a result of dental caries will be compared.
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67817)
Trial website
Publications 1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20465831
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22983408
Contact name Dr  Rosamund  Harrison
  Address 2199 Wesbrook Mall
  City/town Vancouver, BC
  Zip/Postcode V6T 1Z3
  Country Canada
  Tel +1 604 822 2094
  Fax +1 604 822 3562
  Email rosha@interchange.ubc.ca
Sponsor Canadian Institutes of Health Research (CIHR) (Canada)
  Address Room 97
160 Elgin Street
Address locator: 4809A
  City/town Ottawa, ON
  Zip/Postcode K1A OW9
  Country Canada
  Tel +1 888 603 4178
  Fax +1 613 954 1800
  Email info@cihr-irsc.gc.ca
  Sponsor website: http://www.cihr-irsc.gc.ca/
Date applied 29/06/2004
Last edited 04/01/2013
Date ISRCTN assigned 22/07/2004
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.