TerminatedNot Applicable

Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project

Stopped: Safety concerns for study participants and non-feasibility of enrollment due to the COVID-19 pandemic.

United States16 participantsStarted 2021-03-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * • 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Decayed, Missing and/or Filled Primary Tooth Surfaces (Dmfs)

Timeframe: 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.

Trial details

NCT IDNCT04556175

SponsorNorthern Arizona University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

Results submitted2025-08-12

View on ClinicalTrials.gov More Early Childhood Caries trials