Early Childhood CariesNCT04556175
Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
A study testing Oral Health and Healthy Lifestyle in people with Early Childhood Caries and Dental Caries, run by Northern Arizona University at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a bundled best practices oral health intervention utilizing motivational interviewing versus a didactic maternal and child healthy lifestyle intervention will reduce childrens' decayed, missing and/or filled primary tooth surfaces (dmfs) measured over a 2-3 year period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries, Dental Caries
- What is being tested?
- Oral Health and Healthy Lifestyle
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Be willing and able to follow study procedures and instructions and be available for the duration of the study
- Be at least 18 years of age (mother)
- Be American Indian or giving birth to an AI child, and living on or near (approximately 100 miles) the Hopi or Crow nations. American Indian status is self-identified-no tribal enrollment verification will be required.
- Be currently pregnant-preferably in month 4 of pregnancy at enrollment but mothers are eligible when 3-7 months pregnant.
- Be willing to participate until the child is age 3
- Mothers of twins will be included, but only one child will be enrolled as the study child.
Who cannot join
- • Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
- Enrolled in other community health interventions that incorporate oral health intervention.
- A member of the Northern Cheyenne Tribe
- Living on the Navajo Nation and a member of the Navajo Tribe
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Little Big Horn College
Crow Agency, Montana, 59022-0001
The Hopi Tribe, Department of Health and Human Services
Kykotsmovi, Arizona, 86039
About this study
The purpose of this study is to determine whether a bundled best practices oral health intervention utilizing motivational interviewing versus a didactic maternal and child healthy lifestyle intervention will reduce childrens' decayed, missing and/or filled primary tooth surfaces (dmfs) measured over a 2-3 year period.
Read the detailed description
Early Childhood Caries (ECC) is the most common chronic disease among children. American Indian (AI) children are 4 times more likely to have untreated dental decay than white children. This is a four year parallel group randomized clinical trial evaluating the impact of a bundled best practices oral health intervention on early childhood caries in American Indian children as indicated by the number of decayed, missing and/or filled primary tooth surfaces (dmfs). The intervention is delivered during pregnancy and through child age 24-36 months. The bundled best practices include motivational interviewing with mothers and fluoride varnish applied to the child's teeth. The oral health intervention also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. The oral health intervention group (n=175 mother-child dyads) will be compared to a group (n=175 mother-child dyads) receiving a standard prenatal/postnatal healthy lifestyle intervention. This comparison Healthy Lifestyle intervention is designed to improve maternal/child health knowledge and also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. Children in both groups receive some fluoride varnish. All study treatments will be delivered by Community Health Representatives from two Tribal communities in the Western U.S. Children and caregivers will be followed until up to 3 years of age. The primary outcome measure is the average number of decayed, missing and/or filled primary tooth surfaces (dmfs) at the last follow up (24 months for the late enrollment cohort; 30-36 months of age for the early enrollment cohort). Secondary outcomes include 1) the average number of decayed, missing and/or filled primary teeth (dmft) at the last follow up; survey based measures of 2) oral health knowledge; 3) oral health behavior; 4) attitudes towards oral health care; and 5) knowledge of maternal health and child development (e.g., pregnancy related nutrition; breastfeeding; prenatal health).
- Conditions
- Early Childhood Caries, Dental Caries
- Being tested
- Oral Health, Healthy Lifestyle
- Keywords
- child, infant, mothers, pregnant women, dental caries, American Indian, North, motivational interviewing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral HealthBehavioural
Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
Healthy LifestyleBehavioural
Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
| Study group | Role | What they receive |
|---|---|---|
| Oral Health | Experimental | Motivational interviewing sessions will involve in-person visits by Community Health Workers focused on the mitigation of behavioral risk factors for early childhood caries, with two sessions provided before childbirth and four more sessions at 6, 12, 18 and 24 months after childbirth. Children receive up to 4 fluoride varnish applications during the study. Early cohort of enrollees will be followed up in a 7th visit solely for oral health assessment. Receives: Behavioral: Oral Health |
| Healthy Lifestyle | Active comparator | Didactic educational sessions delivered in-person by Community Health Workers cover nutrition and diet, physical activity, breastfeeding/formula feeding, substance use, mental/emotional health, personal and family goals, prenatal/postpartum health care access, labor and delivery, family support, infant/child care, oral health, and development milestones. Children receive up to 2 fluoride varnish applications during the study. Early cohort enrollees will be followed up in a 7th visit solely for oral health assessment. Receives: Behavioral: Healthy Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs)
For dmfs, there are five surfaces counted on the posterior teeth: facial, lingual, mesial, distal, and occlusal. There are four surfaces counted on anterior teeth: facial, lingual, mesial, and distal. The total tooth count is 20 (8 posterior and 12 anterior) equaling a total of 88 surfaces possible. Each tooth surface will be scored using one of the following mutually exclusive categories; cavitated decayed lesion; filled surface (amalgam); filled surface (non-amalgam); sealed surface; unerupted surface; unable to score. The primary outcome measure is the count of all surfaces scored as cavitated decayed lesion/filled surface/missing due to caries for each individual.
Measured: The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the primary outcome measure.
Secondary outcomes (4)
Number of Decayed, Missing or Filled Primary Teeth (Dmft)
This is a count of the number of teeth with one or more decayed, missing or filled surfaces. This is calculated by counting teeth, rather than tooth surfaces, using the primary outcome assessment (dmfs). If no teeth have been filled or are missing due to disease this outcome is called dt rather than dmft.
Measured: The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the secondary outcome measure.
Oral Health Knowledge of Mothers/Caregivers
Percentage of correct responses to 18 knowledge questions based upon the Basic Research Factors Questionnaire. There are six true/false questions, 8 Likert-type judgements of whether certain behaviors are good for a child's teeth, and 4 multiple choice questions regarding infant/child oral health care.
Measured: Oral health knowledge among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months).
Oral Health Behavior of Mothers/Caregivers
Percentage of correct responses to 12 questions regarding oral health behavior. Eleven are based upon the Basic Research Factors Questionnaire (Wilson et al. Pediatr Dent 2016;38:47-54) and one is based on study-specific question formative assessments. Items include three questions regarding dental health care utilization, seven questions regarding parental involvement in oral health care for self and child and two questions regarding consumption of sweets/sugar.
Measured: Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).
Attitudes Towards Oral Health Care of Mothers/Caregivers
Sum of Likert-type ratings for 14 items. Scores range from 14 (lowest) to 70 (highest) with higher scores representing more favorable attitudes towards child oral health care.
Measured: Attitudes towards oral health among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start29 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Why it stopped: Safety concerns for study participants and non-feasibility of enrollment due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Centralized, computer-based group assignment using permuted blocks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Julie Baldwin, Northern Arizona University
- Investigators
- Julie A Baldwin, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556175
- Sponsor's protocol ID
- 1396150
- Other IDs
- 1U01DE028508-01
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2020
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project
- ClinicalTrials.gov ID
- NCT04556175
- Acronym / sponsor ID
- 1396150
- Conditions
- Early Childhood Caries, Dental Caries
- Keywords
- child, infant, mothers, pregnant women, dental caries, American Indian, North, motivational interviewing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns for study participants and non-feasibility of enrollment due to the COVID-19 pandemic.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 29 Aug 2025
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 bundled best practices oral health intervention utilizing motivational interviewing versus a didactic maternal and child healthy lifestyle intervention will reduce childrens' decayed, missing and/or filled primary tooth surfaces (dmfs) measured over a 2-3 year period.
Detailed description
Early Childhood Caries (ECC) is the most common chronic disease among children. American Indian (AI) children are 4 times more likely to have untreated dental decay than white children. This is a four year parallel group randomized clinical trial evaluating the impact of a bundled best practices oral health intervention on early childhood caries in American Indian children as indicated by the number of decayed, missing and/or filled primary tooth surfaces (dmfs). The intervention is delivered during pregnancy and through child age 24-36 months. The bundled best practices include motivational interviewing with mothers and fluoride varnish applied to the child's teeth. The oral health intervention also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. The oral health intervention group (n=175 mother-child dyads) will be compared to a group (n=175 mother-child dyads) receiving a standard prenatal/postnatal healthy lifestyle intervention. This comparison Healthy Lifestyle intervention is designed to improve maternal/child health knowledge and also includes Tribe-specific individual, social and health needs identified in an earlier formative assessment. Children in both groups receive some fluoride varnish. All study treatments will be delivered by Community Health Representatives from two Tribal communities in the Western U.S. Children and caregivers will be followed until up to 3 years of age. The primary outcome measure is the average number of decayed, missing and/or filled primary tooth surfaces (dmfs) at the last follow up (24 months for the late enrollment cohort; 30-36 months of age for the early enrollment cohort). Secondary outcomes include 1) the average number of decayed, missing and/or filled primary teeth (dmft) at the last follow up; survey based measures of 2) oral health knowledge; 3) oral health behavior; 4) attitudes towards oral health care; and 5) knowledge of maternal health and child development (e.g., pregnancy related nutrition; breastfeeding; prenatal health).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Centralized, computer-based group assignment using permuted blocks.
| Arm | Type | Receives |
|---|---|---|
| Oral Health | Experimental | Behavioral: Oral HealthMotivational interviewing sessions will involve in-person visits by Community Health Workers focused on the mitigation of behavioral risk factors for early childhood caries, with two sessions provided before childbirth and four more sessions at 6, 12, 18 and 24 months after childbirth. Children receive up to 4 fluoride varnish applications during the study. Early cohort of enrollees will be followed up in a 7th visit solely for oral health assessment. |
| Healthy Lifestyle | Active comparator | Behavioral: Healthy LifestyleDidactic educational sessions delivered in-person by Community Health Workers cover nutrition and diet, physical activity, breastfeeding/formula feeding, substance use, mental/emotional health, personal and family goals, prenatal/postpartum health care access, labor and delivery, family support, infant/child care, oral health, and development milestones. Children receive up to 2 fluoride varnish applications during the study. Early cohort enrollees will be followed up in a 7th visit solely for oral health assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide signed and dated informed consent form
- Be willing and able to follow study procedures and instructions and be available for the duration of the study
- Be at least 18 years of age (mother)
- Be American Indian or giving birth to an AI child, and living on or near (approximately 100 miles) the Hopi or Crow nations. American Indian status is self-identified-no tribal enrollment verification will be required.
- Be currently pregnant-preferably in month 4 of pregnancy at enrollment but mothers are eligible when 3-7 months pregnant.
Key exclusion criteria (4 listed)
- • Anything that would place the individual at increased risk or preclude the individual's full compliance with, or completion of, the study.
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 |
|---|---|---|
| Oral HealthMotivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children. | Behavioural | Oral Health |
| Healthy LifestyleDidactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children. | Behavioural | Healthy Lifestyle |
Primary outcome
Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs)
Time frame: The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the primary outcome measure.
For dmfs, there are five surfaces counted on the posterior teeth: facial, lingual, mesial, distal, and occlusal. There are four surfaces counted on anterior teeth: facial, lingual, mesial, and distal. The total tooth count is 20 (8 posterior and 12 anterior) equaling a total of 88 surfaces possible. Each tooth surface will be scored using one of the following mutually exclusive categories; cavitated decayed lesion; filled surface (amalgam); filled surface (non-amalgam); sealed surface; unerupted surface; unable to score. The primary outcome measure is the count of all surfaces scored as cavitated decayed lesion/filled surface/missing due to caries for each individual.
4 secondary outcomes
Number of Decayed, Missing or Filled Primary Teeth (Dmft)
Time frame: The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the secondary outcome measure.
Oral Health Knowledge of Mothers/Caregivers
Time frame: Oral health knowledge among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months).
Oral Health Behavior of Mothers/Caregivers
Time frame: Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).
Attitudes Towards Oral Health Care of Mothers/Caregivers
Time frame: Attitudes towards oral health among mothers/caregivers is assessed at Visits 1 (4-7 months pregnant), 4 (child age 12 months) and 6 (child age 24 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Julie A Baldwin, PhD principal investigator
Northern Arizona University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health and Healthy Lifestyle in people with Early Childhood Caries and Dental Caries, run by Northern Arizona University at 2 sites in United States.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs) (time frame: The outcome will be assessed through study completion, child ages 30-36 months for early cohort; 24 months for late cohort. Differential follow up is planned but only the last assessment time point is the primary outcome measure.). 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 29 Aug 2025.