Phase 3
N=2,060
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Fluoride Varnish and Oral Health Promotion · Usual Care
Bottom Line
View on ClinicalTrials.gov: NCT01116739 ↗Enrolled (actual)
2,060
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline — 19.9; 22.8 dmfs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluoride varnish (Device); Oral health education (Behavioral); Dental services delivered by the Indian Health Service. (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline |
19.9; 22.8 | — |
| PRIMARY Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 |
23.3; 27.1 | — |
| PRIMARY Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 |
28.5; 31.2 | — |
| PRIMARY Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 |
32.8; 33.6 | — |
| SECONDARY Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children |
54.4; 56.1; 62.7; 58.2; 63.4; 61.1 | — |
| SECONDARY Evaluation of Caries Patterns |
86.5; 90.1; 89.9; 90.9; 95.4; 96.1 | — |
| SECONDARY Comparison of Utilization and Costs of Dental Care |
— | — |
| SECONDARY Acquisition of Dental Knowledge of the Caregivers of the Children |
75.1; 73.6; 80.4; 76.8; 81.4; 78.0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01116739). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.