Dental caries prevention program for Cree mothers and infants
| ISRCTN | ISRCTN41467632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41467632 |
| Secondary identifying numbers | MCT-67817 |
- Submission date
- 29/06/2004
- Registration date
- 22/07/2004
- Last edited
- 04/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rosamund Harrison
Scientific
Scientific
2199 Wesbrook Mall
Vancouver, BC
V6T 1Z3
Canada
| Phone | +1 604 822 2094 |
|---|---|
| rosha@interchange.ubc.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A clinical trial of the effectiveness of a dental caries prevention program for Cree mothers and their infants |
| Study acronym | CreeC |
| Study objectives | 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 mothers 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(s) | University of British Columbia (UBC) Behavioural Research Ethics Board (ref: Certificate B04-0295) - this is re-approved annually. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 childs 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 study start date | 01/04/2004 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 309 |
| Key inclusion criteria | 1. 309 Cree mother-child pairs in Eeyou Istchee (Cree territory of northern Quebec) 2. Mothers aged 18 - 49 years old |
| Key exclusion criteria | Any pregnant women or woman with a newborn who knows that she will be imminently moving out of the Cree territory. |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- Canada
Study participating centre
2199 Wesbrook Mall
Vancouver, BC
V6T 1Z3
Canada
V6T 1Z3
Canada
Sponsor information
Canadian Institutes of Health Research (CIHR) (Canada)
Research organisation
Research organisation
Room 97
160 Elgin Street
Address locator: 4809A
Ottawa, ON
K1A OW9
Canada
| Phone | +1 888 603 4178 |
|---|---|
| info@cihr-irsc.gc.ca | |
| Website | http://www.cihr-irsc.gc.ca/ |
"ROR" |
https://ror.org/01gavpb45 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67817)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/05/2010 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No |
