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Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study (BTT)

Primary Purpose

Dental Caries, Early Childhood Caries

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Dental care, AG, MI & fluoride varnish
Delayed intervention
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries, early childhood caries, topical fluorides, fluoride varnish

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toronto Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Dental care, AG, MI & fluoride varnish

Delayed intervention

Arm Description

The intervention comprises four components; provision of dental care to the mother during pregnancy (2nd trimester), preventive treatment with fluoride varnish to the teeth of children, and two behavioral interventions, namely oral health anticipatory guidance and motivational interviewing with the caregiver/mother.

Three fluoride varnish applications to the teeth of children and oral health anticipatory guidance and motivational interviewing for the caregiver when the child is aged 24, 30 and 36 months. Dental care also will be offered to the mothers/caregivers in the delayed intervention group when their children are aged 2 to 3 years old. Before the children are aged 2 years, standard dental care will be the comparator, which usually involves provision of dental care only if the participant is in pain.

Outcomes

Primary Outcome Measures

Child dental caries incidence and increment, as measured by the dmft/s Indices
Child dental caries experience at age 2 years will be used to calculate the 2-year caries incidence and increment, as no child is born with dental caries.

Secondary Outcome Measures

Caregiver oral health knowledge
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Caregiver oral self-care
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Caregiver dental service utilization
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Caregiver oral health-related self-efficacy
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Caregiver oral health literacy
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.

Full Information

First Posted
May 27, 2014
Last Updated
May 29, 2014
Sponsor
University of Toronto
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02151916
Brief Title
Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study
Acronym
BTT
Official Title
Reducing Disease Burden and Health Inequalities Arising From Chronic Dental Disease Among Indigenous Children: an Early Childhood Caries Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Early Childhood Caries
Keywords
dental caries, early childhood caries, topical fluorides, fluoride varnish

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental care, AG, MI & fluoride varnish
Arm Type
Experimental
Arm Description
The intervention comprises four components; provision of dental care to the mother during pregnancy (2nd trimester), preventive treatment with fluoride varnish to the teeth of children, and two behavioral interventions, namely oral health anticipatory guidance and motivational interviewing with the caregiver/mother.
Arm Title
Delayed intervention
Arm Type
Other
Arm Description
Three fluoride varnish applications to the teeth of children and oral health anticipatory guidance and motivational interviewing for the caregiver when the child is aged 24, 30 and 36 months. Dental care also will be offered to the mothers/caregivers in the delayed intervention group when their children are aged 2 to 3 years old. Before the children are aged 2 years, standard dental care will be the comparator, which usually involves provision of dental care only if the participant is in pain.
Intervention Type
Other
Intervention Name(s)
Dental care, AG, MI & fluoride varnish
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Delayed intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child dental caries incidence and increment, as measured by the dmft/s Indices
Description
Child dental caries experience at age 2 years will be used to calculate the 2-year caries incidence and increment, as no child is born with dental caries.
Time Frame
from birth to 2 years
Secondary Outcome Measure Information:
Title
Caregiver oral health knowledge
Description
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Time Frame
from preconception to 3 years post-partum
Title
Caregiver oral self-care
Description
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Time Frame
from preconception to 3 years post-partum
Title
Caregiver dental service utilization
Description
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Time Frame
from preconception to 3 years post-partum
Title
Caregiver oral health-related self-efficacy
Description
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Time Frame
from preconception to 3 years post-partum
Title
Caregiver oral health literacy
Description
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Time Frame
from preconception to 3 years post-partum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herenia P. Lawrence, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto Faculty of Dentistry
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1G6
Country
Canada

12. IPD Sharing Statement

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Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study

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