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

NCT02151916 | Unknown Phase 3 DMC

• 1 other identifier: IDP-103988
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Early Childhood Caries

Keywords

dental caries; early childhood caries; topical fluorides; fluoride varnish

Outcome Measures

Primary Outcomes (1)

• 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.

  from birth to 2 years

Secondary Outcomes (5)

• Caregiver oral health knowledge

  from preconception to 3 years post-partum

• Caregiver oral self-care

  from preconception to 3 years post-partum

• Caregiver dental service utilization

  from preconception to 3 years post-partum

• Caregiver oral health-related self-efficacy

  from preconception to 3 years post-partum

• Caregiver oral health literacy

  from preconception to 3 years post-partum

Study Arms (2)

Dental care, AG, MI & fluoride varnish

EXPERIMENTAL

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.

Other: Dental care, AG, MI & fluoride varnish

Delayed intervention

OTHER

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.

Other: Delayed intervention

Interventions

Dental care, AG, MI & fluoride varnish OTHER

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.

Dental care, AG, MI & fluoride varnish

Delayed intervention OTHER

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.

Delayed intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• University of Manitoba: collaborator

Study Sites (1)

University of Toronto Faculty of Dentistry

Toronto, Ontario, M5G 1G6, Canada

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Herenia P. Lawrence, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 2, 2014
• Study Start: June 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

CA (1)