Fluoride Varnish and Oral Health Promotion, Usual Care
Conditions
Brief summary
An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for children in American Indian Head Start Programs.
Detailed description
The study design will be a clustered randomized design. Fifty-two head start classes in a Southwest American Indian Reservation will be randomized, 26 to the intervention program and 26 to usual care. The intervention will be comprised of specially trained paraprofessionals, called community oral health specialists (COHS), administering fluoride varnish and oral health promotion education quarterly for 2 years. Baseline and annual measures of decayed, missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers' dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year study, with 2 years for intake/accrual, and 3 years of follow-up.
Interventions
DEVICEFluoride varnish
Fluoride varnish will be administered by the COHS quarterly for 2 years.
BEHAVIORALOral 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.
OTHERDental services delivered by the Indian Health Service.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC) * American Indian, as defined by the tribe, or * Children of other racial/ethnic groups who are in the Head Start classes on the Reservation * Parent/caregiver able to read, understand, and sign the study consent form, and * Willing and able to follow the study procedures and instructions
Exclusion criteria
* Allergy to any of the components of the fluoride varnish * Ulcerative gingivitis * Stomatitis * Other conditions resulting in disrupted or irritated oral mucosa * Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 | 3 Years | 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. |
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline | Baseline | 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. |
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 | 1 Year | 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. |
| Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 | 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Over 3 years | 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. |
| Evaluation of Caries Patterns | Over 3 years | 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. |
| Comparison of Utilization and Costs of Dental Care | Up to 3 years after randomization | 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. |
| Acquisition of Dental Knowledge of the Caregivers of the Children | Over 3 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 926 |
| Usual Care Usual care will include regular dental services provided by the Indian Health Service.
Dental services delivered by the Indian Health Service. | 868 |
| Total | 1,794 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Child had 2 years of HS | 110 | 128 |
| Overall Study | child not enrolled in head start | 10 | 2 |
| Overall Study | child too young | 2 | 6 |
| Overall Study | enrolled caregiver not legal guardian | 2 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 0 |
Baseline characteristics
| Characteristic | COHS Administered Fluoride Varnish and Oral Health Education | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 463 Participants | 434 Participants | 897 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 463 Participants | 434 Participants | 897 Participants |
| Child Enrolled in a Head Start program in one of 53 centers on the Navajo Nation | 926 Participants | 868 Participants | 1794 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 926 Participants | 868 Participants | 1794 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 926 participants | 868 participants | 1794 participants |
| Sex: Female, Male Female | 621 Participants | 582 Participants | 1203 Participants |
| Sex: Female, Male Male | 305 Participants | 286 Participants | 591 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 926 | 0 / 868 |
| other Total, other adverse events | 0 / 926 | 0 / 868 |
| serious Total, serious adverse events | 0 / 926 | 0 / 868 |
Outcome results
Primary
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
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.
Time frame: Baseline
Population: Only children, not parents, were analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline | 19.9 dmfs | Standard Deviation 20.1 |
| Usual Care | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline | 22.8 dmfs | Standard Deviation 20.1 |
Primary
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
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.
Time frame: 1 Year
Population: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 | 23.3 dmfs | Standard Deviation 20.4 |
| Usual Care | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 | 27.1 dmfs | Standard Deviation 21.5 |
Primary
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
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.
Time frame: 2 Years
Population: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 | 28.5 dmfs | Standard Deviation 21.1 |
| Usual Care | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 | 31.2 dmfs | Standard Deviation 21.3 |
Primary
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
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.
Time frame: 3 Years
Population: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 | 32.8 dmfs | Standard Deviation 22.3 |
| Usual Care | Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 | 33.6 dmfs | Standard Deviation 18.6 |
Secondary
Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
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.
Time frame: Over 3 years
Population: Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Baseline | 54.4 score on a scale | Standard Deviation 19.3 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 2 | 63.4 score on a scale | Standard Deviation 18.7 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 1 | 62.7 score on a scale | Standard Deviation 18.8 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 3 | 65.6 score on a scale | Standard Deviation 18.9 |
| Usual Care | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 1 | 58.2 score on a scale | Standard Deviation 19.6 |
| Usual Care | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Baseline | 56.1 score on a scale | Standard Deviation 18.3 |
| Usual Care | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 3 | 66.4 score on a scale | Standard Deviation 17.6 |
| Usual Care | Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children | Year 2 | 61.1 score on a scale | Standard Deviation 18.3 |
Secondary
Acquisition of Dental Knowledge of the Caregivers of the Children
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.
Time frame: Over 3 years
Population: Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Knowledge of the Caregivers of the Children | Baseline | 75.1 score on a scale | Standard Deviation 30.7 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 1 | 80.4 score on a scale | Standard Deviation 13.1 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 2 | 81.4 score on a scale | Standard Deviation 14.8 |
| COHS Administered Fluoride Varnish and Oral Health Education | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 3 | 81.2 score on a scale | Standard Deviation 13.4 |
| Usual Care | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 3 | 79.5 score on a scale | Standard Deviation 12.8 |
| Usual Care | Acquisition of Dental Knowledge of the Caregivers of the Children | Baseline | 73.6 score on a scale | Standard Deviation 13.1 |
| Usual Care | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 2 | 78.0 score on a scale | Standard Deviation 13.2 |
| Usual Care | Acquisition of Dental Knowledge of the Caregivers of the Children | Year 1 | 76.8 score on a scale | Standard Deviation 13.5 |
Secondary
Comparison of Utilization and Costs of Dental Care
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.
Time frame: Up to 3 years after randomization
Population: Cost and utilization outcome measure data was not collected.
Secondary
Evaluation of Caries Patterns
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.
Time frame: Over 3 years
Population: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Caries Patterns | Baseline | 86.5 percentage of participants |
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Caries Patterns | Year 1 | 89.9 percentage of participants |
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Caries Patterns | Year 2 | 95.4 percentage of participants |
| COHS Administered Fluoride Varnish and Oral Health Education | Evaluation of Caries Patterns | Year 3 | 96.6 percentage of participants |
| Usual Care | Evaluation of Caries Patterns | Year 3 | 98.2 percentage of participants |
| Usual Care | Evaluation of Caries Patterns | Baseline | 90.1 percentage of participants |
| Usual Care | Evaluation of Caries Patterns | Year 2 | 96.1 percentage of participants |
| Usual Care | Evaluation of Caries Patterns | Year 1 | 90.9 percentage of participants |