Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study
NCT02151916 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544
Last updated 2014-06-02
Summary
The purpose of this study is to determine whether a combination of pre- and post-natal preventive and behavioral interventions is effective in preventing early childhood caries in Indigenous children.
Early childhood caries (ECC) causes profound suffering, frequently requiring expensive treatment under a general anesthetic. It is associated with other chronic childhood conditions such as otitis media and nutritional disorders, and is the strongest predictor of poor oral health in adulthood. Despite ECC being entirely preventable, marked ECC disparities exist between Indigenous and non-Indigenous children in Australia, New Zealand and Canada. If the burden of ECC and associated oral health inequalities experienced by Indigenous children in these nations are to be reduced, more needs to be done to ensure that appropriate preventive measures, together with support for maintaining optimal oral health, are provided to caregivers of such children in the early life stages. This will be an interventional study, with all participants receiving the intervention benefits. Pregnant Indigenous women residing in the three countries, their families and communities will be included. The intervention will be implemented from birth and continue for the first three years of a participating child's life. It will involve four components; dental care provided to the mother during pregnancy, fluoride varnish applications for the child, oral health anticipatory guidance and motivational interviewing. Following an Indigenous research framework and methodology, the intervention will be tailored at the individual- or family-level, with each caregiver or family progressing to the next level only when they are ready. Developing a culturally-appropriate ECC intervention that aims to improve child oral health, in full partnership with the Indigenous communities involved, will provide much needed evidence for policy makers to address the challenge of improved oral health and related outcomes for Indigenous children.
Conditions
- Dental Caries
- Early Childhood Caries
Interventions
- OTHER
-
Dental care, AG, MI & fluoride varnish
Dental care during pregnancy, or soon thereafter, will comprise of a screening oral examination, extractions, restorations, scaling and prophylaxis, if needed, and will take as many dental visits as required to achieve a non-diseased mouth. Fluoride varnish application to the teeth of children in the immediate intervention group will occur when children are aged 6 to 10 months (time of tooth eruption), 12 and 18 months, as well as at 24 months. Oral health anticipatory guidance and motivational interviewing for the caregivers/mothers in the immediate intervention group will occur during pregnancy and when the children are aged 6-10 months (time of tooth eruption), 12 and 18 months.
- OTHER
-
Delayed intervention
Delayed intervention controlled design; all participants ultimately receive the benefits of the interventions. The intervention group receives the interventions when the mother is pregnant until the child is two years old. The delayed intervention group receives the interventions when the child is two years old until the child is three years old.
Sponsors & Collaborators
-
University of Manitoba
collaborator OTHER -
University of Toronto
lead OTHER
Principal Investigators
-
Herenia P. Lawrence, PhD · University of Toronto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-06-30
- Primary Completion
- 2015-07-31
- Completion
- 2016-07-31
Countries
- Canada
Study Locations
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