Trials Sponsors Conditions Drugs Pricing

Conditions

Dental Caries Early Childhood Caries

Keywords

childinfantmotherspregnant womendental cariesAmerican Indian, Northmotivational interviewing

Outcome Measures

Primary Outcomes (1)

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.
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)
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
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
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
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).

Study Arms (2)

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.

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.

Behavioral: Healthy Lifestyle

Interventions

Oral HealthBehavioral

Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.

Oral Health

Healthy LifestyleBehavioral

Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.

Healthy Lifestyle

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Northern Arizona University
Otherlead
National Institute of Dental and Craniofacial Research (NIDCR)
NIHcollaborator

Study Sites (2)

The Hopi Tribe, Department of Health and Human Services

Kykotsmovi, Arizona, 86039, United States

Little Big Horn College

Crow Agency, Montana, 59022-0001, United States

MeSH Terms

Conditions

Dental Caries

Interventions

Oral Health

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Results Point of Contact

Title: Dr Julie Baldwin
Organization: Northern Arizona University

Study Officials

Julie A Baldwin, PhD
Northern Arizona University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Regents' Professor; Director, Center for Health Equity Research

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 21, 2020

Study Start

March 29, 2021

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Oral Health

Healthy Lifestyle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations