Clinical trial NCT02151916: Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study
Official title: Reducing Disease Burden and Health Inequalities Arising From Chronic Dental Disease Among Indigenous Children: an Early Childhood Caries Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dental Caries
Early Childhood Caries
Keywords: dental caries
early childhood caries
topical fluorides
fluoride varnish
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2014-06-02
Enrollment: 544
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The study seeks to determine whether the implementation of a culturally-appropriate early childhood caries intervention reduces dental disease burden and oral health inequalities among Indigenous children. The study is part of a tri-nation research project entitled "Reducing disease burden and health inequalities arising from chronic dental disease among Indigenous children: an early childhood caries intervention", being simultaneously conducted in Canada, Australia, and New Zealand. It was created in response to a Request for Applications for the International Collaborative Indigenous Health Research Partnership (ICIHRP) grant - a funding initiative of the Canadian Institutes of Health Research, the Health Research Council of New Zealand and the National Health and Medical Research Council of Australia.

The Baby Teeth Talk (BTT) Study, the Canadian arm of the project, is a community-based participatory research project being conducted in partnership with Aboriginal communities and organizations. BTT targets expectant mothers and their newborns, over a three-year intervention period. BTT has successfully recruited over 500 pregnant First Nations and Metis women living in urban and on-reserve communities in Ontario and Manitoba in the past two and a half years. This 5-year study promotes and offers good dental care during pregnancy and uses Motivational Interviewing (MI) and Anticipatory Guidance (AG) to counsel mothers on caring for their children's teeth. Presently, study participants have all given birth and fluoride varnish is being applied to their babies' teeth twice per year for 3 years by First Nations and non-First Nations community-based researchers associated with the project. At the same time, mothers continue to receive MI and AG in an effort to address the dietary and oral health concerns of their children. The goal of the study's multi-pronged approach is to intervene early enough in the child's life to prevent the onset of early childhood caries, or at least, reduce the rates of the disease to levels comparable to the general Canadian population so that fewer Indigenous children require dental treatment under general anesthesia.

The investigators have currently started the clinical oral examinations of the 2-year-old participants to assess the effectiveness of the investigators pre- and post-natal preventive and behavioral interventions to prevent caries in young Indigenous children. This is the point when the investigators collect the primary outcome data for the investigators project.

Eligibility criteria: Inclusion Criteria:

* Women who identify themselves as one of the Aboriginal Peoples in Canada (First Nations, Metis, Inuit) and/or who are pregnant with an Aboriginal child and live in the designated study areas.

Exclusion Criteria:

* Women who do not identify themselves as one of the Indigenous Peoples in Canada or are not pregnant with an Aboriginal child or do not live in the designated study areas.

Primary outcomes:
measure: Child dental caries incidence and increment, as measured by the dmft/s Indices
timeFrame: from birth to 2 years
Secondary outcomes:
measure: Caregiver oral health knowledge
timeFrame: from preconception to 3 years post-partum
measure: Caregiver oral self-care
timeFrame: from preconception to 3 years post-partum
measure: Caregiver dental service utilization
timeFrame: from preconception to 3 years post-partum
measure: Caregiver oral health-related self-efficacy
timeFrame: from preconception to 3 years post-partum
measure: Caregiver oral health literacy
timeFrame: from preconception to 3 years post-partum
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto Faculty of Dentistry
state: Ontario
Study officials:
affiliation: University of Toronto
name: Herenia P. Lawrence, PhD
role: PRINCIPAL_INVESTIGATOR
References: