Dental CariesPhase 3BTTNCT02151916
Preventing Early Childhood Caries in Indigenous Children: the Baby Teeth Talk Study
A Phase 3 study testing Dental care, AG, MI & fluoride varnish and Delayed intervention in people with Dental Caries and Early Childhood Caries, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dental Caries, Early Childhood Caries
- What is being tested?
- Dental care, AG, MI & fluoride varnish and Delayed intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto Faculty of Dentistry
Toronto, Ontario, M5G 1G6
About this study
Official title: Reducing Disease Burden and Health Inequalities Arising From Chronic Dental Disease Among Indigenous Children: an Early Childhood Caries Intervention
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.
Read the 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.
- Conditions
- Dental Caries, Early Childhood Caries
- Being tested
- Dental care, AG, MI & fluoride varnish, Delayed intervention
- Keywords
- dental caries, early childhood caries, topical fluorides, fluoride varnish
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental care, AG, MI & fluoride varnishOther
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.
Delayed interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from birth to 2 years
Secondary outcomes (5)
Caregiver oral health knowledge
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Measured: from preconception to 3 years post-partum
Caregiver oral self-care
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Measured: from preconception to 3 years post-partum
Caregiver dental service utilization
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Measured: from preconception to 3 years post-partum
Caregiver oral health-related self-efficacy
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Measured: from preconception to 3 years post-partum
Caregiver oral health literacy
Assessed by comparing results from the caregiver baseline and 2- and 3-year follow-up questionnaires.
Measured: from preconception to 3 years post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Herenia P. Lawrence, University of Toronto
- Investigators
- Herenia P. Lawrence, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151916
- Sponsor's protocol ID
- IDP-103988
- Acronym
- BTT
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disease Burden and Health Inequalities Arising From Chronic Dental Disease Among Indigenous Children: an Early Childhood Caries Intervention
- ClinicalTrials.gov ID
- NCT02151916
- Acronym / sponsor ID
- BTT / IDP-103988
- Conditions
- Dental Caries, Early Childhood Caries
- Keywords
- dental caries, early childhood caries, topical fluorides, fluoride varnish
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 544 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental care, AG, MI & fluoride varnish | Experimental | Other: Dental care, AG, MI & fluoride varnishThe 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. |
| Delayed intervention | Other | Other: Delayed interventionThree 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental care, AG, MI & fluoride varnishDental 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 | Dental care, AG, MI & fluoride varnish |
| Delayed interventionDelayed 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. | Other | Delayed intervention |
Primary outcome
Child dental caries incidence and increment, as measured by the dmft/s Indices
Time frame: from birth to 2 years
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.
5 secondary outcomes
Caregiver oral health knowledge
Time frame: from preconception to 3 years post-partum
Caregiver oral self-care
Time frame: from preconception to 3 years post-partum
Caregiver dental service utilization
Time frame: from preconception to 3 years post-partum
Caregiver oral health-related self-efficacy
Time frame: from preconception to 3 years post-partum
Caregiver oral health literacy
Time frame: from preconception to 3 years post-partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herenia P. Lawrence, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dental care, AG, MI & fluoride varnish and Delayed intervention in people with Dental Caries and Early Childhood Caries, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child dental caries incidence and increment, as measured by the dmft/s Indices (time frame: from birth to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.