Trial Outcomes & Findings for Great Beginnings for Healthy Native Smiles: An Early Childhood Caries Prevention Project (NCT NCT04556175)
NCT ID: NCT04556175
Last Updated: 2025-08-29
Results Overview
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.
TERMINATED
NA
16 participants
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.
2025-08-29
Participant Flow
Participant milestones
| Measure |
Oral Health
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.
Oral Health: Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Healthy Lifestyle
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.
Healthy Lifestyle: Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Oral Health
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.
Oral Health: Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Healthy Lifestyle
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.
Healthy Lifestyle: Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
|
|---|---|---|
|
Overall Study
Study terminated due to COVID-19
|
8
|
8
|
Baseline Characteristics
There was missing age for one participant
Baseline characteristics by cohort
| Measure |
Oral Health
n=8 Participants
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.
Oral Health: Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Healthy Lifestyle
n=8 Participants
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.
Healthy Lifestyle: Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 6.6 • n=7 Participants • There was missing age for one participant
|
27.3 years
STANDARD_DEVIATION 4.6 • n=8 Participants • There was missing age for one participant
|
27.7 years
STANDARD_DEVIATION 5.4 • n=15 Participants • There was missing age for one participant
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
PRIMARY outcome
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.Population: Trial was terminated before the outcome measure data were collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
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 secondary outcome measure.Population: Trial was terminated before the outcome measure data were collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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).Population: Trial was terminated before the outcome measure data were collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Oral health behavior among mothers/caregivers is assessed at Visits 4 (child age 12 months) and 6 (child age 24 months).Population: Trial was terminated before the outcome measure data were collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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).Population: Trial was terminated before the outcome measure data were collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Oral Health
Healthy Lifestyle
Serious adverse events
| Measure |
Oral Health
n=8 participants at risk
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.
Oral Health: Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
|
Healthy Lifestyle
n=8 participants at risk
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.
Healthy Lifestyle: Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
|
|---|---|---|
|
Infections and infestations
hospitalization
|
12.5%
1/8 • Number of events 1 • 3 months
Adverse events were reported by community health worker staff.
|
0.00%
0/8 • 3 months
Adverse events were reported by community health worker staff.
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage
|
0.00%
0/8 • 3 months
Adverse events were reported by community health worker staff.
|
12.5%
1/8 • Number of events 1 • 3 months
Adverse events were reported by community health worker staff.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place