Condition category
Oral Health
Date applied
29/06/2004
Date assigned
22/07/2004
Last edited
04/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosamund Harrison

ORCID ID

Contact details

2199 Wesbrook Mall
Vancouver
BC
V6T 1Z3
Canada
+1 604 822 2094
rosha@interchange.ubc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-67817

Study information

Scientific title

A clinical trial of the effectiveness of a dental caries prevention program for Cree mothers and their infants

Acronym

CreeC

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 mother’s 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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Early childhood caries or tooth decay

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 child’s experience of caries will be determined by recording the DEFS, or number of decayed, extracted or filled primary tooth surfaces.

Secondary outcome measures

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.

Overall trial start date

01/04/2004

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 309 Cree mother-child pairs in Eeyou Istchee (Cree territory of northern Quebec)
2. Mothers aged 18 - 49 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

309

Participant exclusion criteria

Any pregnant women or woman with a newborn who knows that she will be imminently moving out of the Cree territory.

Recruitment start date

01/04/2004

Recruitment end date

31/03/2010

Locations

Countries of recruitment

Canada

Trial participating centre

2199 Wesbrook Mall
Vancouver, BC
V6T 1Z3
Canada

Sponsor information

Organisation

Canadian Institutes of Health Research (CIHR) (Canada)

Sponsor details

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa
ON
K1A OW9
Canada
+1 888 603 4178
info@cihr-irsc.gc.ca

Sponsor type

Research organisation

Website

http://www.cihr-irsc.gc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67817)

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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20465831
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22983408

Publication citations

  1. Protocol

    Harrison R, Veronneau J, Leroux B, Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities., Trials, 2010, 11, 54, doi: 10.1186/1745-6215-11-54.

  2. Results

    Harrison RL, Veronneau J, Leroux B, Effectiveness of maternal counseling in reducing caries in Cree children., J. Dent. Res., 2012, 91, 11, 1032-1037, doi: 10.1177/0022034512459758.

Additional files

Editorial Notes