Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01116739 ↗
Enrolled (actual)
2,060
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline — 19.9; 22.8 dmfs
◆ Published Evidence
Established
51citations · ~4 / year
Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers.
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.
Linked Publications (5)
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Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers.
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Oral health status in Navajo Nation Head Start children.
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Factors Associated with Oral Health Status in American Indian Children.
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Validation of a pediatric oral health-related quality of life scale in Navajo children.
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Learning from caries-free children in a high-caries American Indian population.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.