Table 3. Fluoride Varnish–Related Adverse Events Among Children With at Least 1 Fluoride Varnish Application, 3 Randomized Controlled Trials Conducted Under the Auspices of the NIDCR-Supported Early Childhood Caries Collaborating Centers.
| Variable | Location of Study Team |
Total | ||
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campusa | University of California, San Franciscob | Boston Universityc | ||
| No. of fluoride varnish applications completed | 1,893 | 3,188 | 5,168 | 10,249 |
| Follow-up on adverse events | ||||
| No. of contact attempts | NAd | 4,612 | 9,157 | 13,769 |
| No. (%) of successful contactse | 1,546 (81.7) | 3,090 (96.9) | 3,912 (75.7) | 8,548 (83.4) |
| Average no. of attempts per contact | NAd | 1.5 | 2.3 | 1.6 |
| Adverse events or serious adverse events that resulted in a medically attended visit | ||||
| No. (%) of all-cause adverse events or serious adverse eventsf | 8 (0.09) | 1 (0.03) | 0 | 9 (0.11) |
| No. of study-related adverse events or serious adverse events | 0 | 0 | 0 | 0 |
Abbreviations: NA, not applicable NIDCR, National Institute of Dental and Craniofacial Research.
a
Intervention group only. Children who enrolled in fall 2011 (n = 55) were eligible for up to 8 fluoride varnish applications. Most children who enrolled in fall 2011 and all children enrolled in fall 2012 were eligible for 4 applications. Fluoride varnish applied 4 times per Head Start school year.
b
Fluoride varnish applied semiannually.
c
Fluoride varnish applied quarterly.
d
Data not electronically recorded.
e
Percentage calculated by using the corresponding number of fluoride varnish applications completed as the denominator.
f
Percentage calculated by using the corresponding number of successful contacts as the denominator.