Trial Outcomes & Findings for Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs (NCT NCT01116739)
NCT ID: NCT01116739
Last Updated: 2021-06-10
Results Overview
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
COMPLETED
PHASE3
2060 participants
Baseline
2021-06-10
Participant Flow
Participant milestones
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Overall Study
STARTED
|
1056
|
1004
|
|
Overall Study
COMPLETED
|
926
|
868
|
|
Overall Study
NOT COMPLETED
|
130
|
136
|
Reasons for withdrawal
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Overall Study
Child had 2 years of HS
|
110
|
128
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
|
Overall Study
child too young
|
2
|
6
|
|
Overall Study
child not enrolled in head start
|
10
|
2
|
|
Overall Study
enrolled caregiver not legal guardian
|
2
|
0
|
Baseline Characteristics
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Baseline characteristics by cohort
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=926 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=868 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
Total
n=1794 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
463 Participants
n=99 Participants
|
434 Participants
n=107 Participants
|
897 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
463 Participants
n=99 Participants
|
434 Participants
n=107 Participants
|
897 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
621 Participants
n=99 Participants
|
582 Participants
n=107 Participants
|
1203 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=99 Participants
|
286 Participants
n=107 Participants
|
591 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
926 Participants
n=99 Participants
|
868 Participants
n=107 Participants
|
1794 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
926 participants
n=99 Participants
|
868 participants
n=107 Participants
|
1794 participants
n=206 Participants
|
|
Child Enrolled in a Head Start program in one of 53 centers on the Navajo Nation
|
926 Participants
n=99 Participants
|
868 Participants
n=107 Participants
|
1794 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Only children, not parents, were analyzed for this outcome measure.
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=443 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=424 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
|
19.9 dmfs
Standard Deviation 20.1
|
22.8 dmfs
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: 1 YearPopulation: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=217 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=231 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
|
23.3 dmfs
Standard Deviation 20.4
|
27.1 dmfs
Standard Deviation 21.5
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=238 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=229 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
|
28.5 dmfs
Standard Deviation 21.1
|
31.2 dmfs
Standard Deviation 21.3
|
PRIMARY outcome
Timeframe: 3 YearsPopulation: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=118 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=111 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
|
32.8 dmfs
Standard Deviation 22.3
|
33.6 dmfs
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Over 3 yearsPopulation: Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.
An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing attitudes and behaviors is comprised of 12 items. Scores are calculated as a percentage of appropriate responses. Therefore, possible scores range from 0-100.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=463 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=434 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Year 1
|
62.7 score on a scale
Standard Deviation 18.8
|
58.2 score on a scale
Standard Deviation 19.6
|
|
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Baseline
|
54.4 score on a scale
Standard Deviation 19.3
|
56.1 score on a scale
Standard Deviation 18.3
|
|
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Year 2
|
63.4 score on a scale
Standard Deviation 18.7
|
61.1 score on a scale
Standard Deviation 18.3
|
|
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Year 3
|
65.6 score on a scale
Standard Deviation 18.9
|
66.4 score on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Over 3 yearsPopulation: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at each timepoint.
Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected. Caries prevalence is defined as the presence of more than 0 dmfs (decayed, missing, or filled surfaces) in the child participant. The percentage of child participants with caries prevalence is reported.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=443 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=424 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Evaluation of Caries Patterns
Year 1
|
89.9 percentage of participants
|
90.9 percentage of participants
|
|
Evaluation of Caries Patterns
Baseline
|
86.5 percentage of participants
|
90.1 percentage of participants
|
|
Evaluation of Caries Patterns
Year 2
|
95.4 percentage of participants
|
96.1 percentage of participants
|
|
Evaluation of Caries Patterns
Year 3
|
96.6 percentage of participants
|
98.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 years after randomizationPopulation: Cost and utilization outcome measure data was not collected.
Utilization and costs of dental care received by the children in the study will be compared, as well as the costs of the intervention program.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Over 3 yearsPopulation: Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.
An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing knowledge is comprised of 14 items. Scores are calculated as a percentage of correct answers. Therefore, possible scores range from 0-100.
Outcome measures
| Measure |
COHS Administered Fluoride Varnish and Oral Health Education
n=463 Participants
Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health education: Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
|
Usual Care
n=434 Participants
Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service.
|
|---|---|---|
|
Acquisition of Dental Knowledge of the Caregivers of the Children
Year 2
|
81.4 score on a scale
Standard Deviation 14.8
|
78.0 score on a scale
Standard Deviation 13.2
|
|
Acquisition of Dental Knowledge of the Caregivers of the Children
Year 3
|
81.2 score on a scale
Standard Deviation 13.4
|
79.5 score on a scale
Standard Deviation 12.8
|
|
Acquisition of Dental Knowledge of the Caregivers of the Children
Baseline
|
75.1 score on a scale
Standard Deviation 30.7
|
73.6 score on a scale
Standard Deviation 13.1
|
|
Acquisition of Dental Knowledge of the Caregivers of the Children
Year 1
|
80.4 score on a scale
Standard Deviation 13.1
|
76.8 score on a scale
Standard Deviation 13.5
|
Adverse Events
COHS Administered Fluoride Varnish and Oral Health Education
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place