Randomized Equivalence Trial of Intensive and Semiannual Applications of Fluoride Varnish in the Primary Dentition

Abstract

For children in the primary dentition with high caries prevalence the standard semiannual application of fluoride varnish may not be successful in preventing tooth decay. Oftentimes this population is mobile and does not receive consistent preventive care. This trial tested whether an intensive fluoride 5% sodium varnish regimen (three applications/2 weeks) applied annually has an equivalent effect on caries progression in the primary dentition compared to single applications applied semiannually. This study was a randomized clinical trial with two treatment groups. All participants (n = 600; mean age ± SD = 55.3 ± 4.6 months) received three varnish applications (active varnish or placebo) at semiannual visits over 3 years. Once per year the intensive-treatment group received one set of three active treatments and three placebo treatments 6 months later, each time within 2 weeks. The standard group received one active and two placebo treatments every 6 months. Children were assessed clinically at baseline and 12, 24 and 36 months after the initiation of the study. The mean (SD) numbers of newly decayed primary tooth surfaces observed over 3 years were 9.8 (8.6) and 7.4 (7.7) in the intensive and standard groups, respectively. The adjusted rate ratio was 1.13 (95% CI = 0.94–1.37, p = 0.20). In conclusion, the trial failed to demonstrate clear evidence of a difference in efficacy. However, differences of up to 36% greater rates of caries in the intensive group could not be ruled out, thus equivalence of the treatments cannot be concluded.

Prevention of Dental Caries in Children From Birth Through Age 5 Years: US Preventive Services Task Force Recommendation Statement

“…Limited evidence found no clear effect on caries increment between performing a single fluoride varnish once every 6 months versus once a year 13 or between a single application every 6 months versus multiple applications once a year or every 6 months. 14,15 Suggestions for Practice Regarding the I Statement…”

“…8,9 Three fair-quality studies evaluated the effect of frequency of fluoride varnish application on caries outcomes. [13][14][15] Two found that multiple fluoride varnish applications within a 2-week period were associated with no statistically significant differences in caries incidence versus a 6-month application schedule. 14,15 One trial found no statistically significant difference in caries rates for once-versus twice-yearly varnish application.…”

“…[13][14][15] Two found that multiple fluoride varnish applications within a 2-week period were associated with no statistically significant differences in caries incidence versus a 6-month application schedule. 14,15 One trial found no statistically significant difference in caries rates for once-versus twice-yearly varnish application. 13 The optimum frequency of fluoride varnish application is not known.…”

Diagnostic and Preventive Approaches for Dental Caries in Children: A Review

“…These combinations provide preventive and antimicrobial properties against Mutans streptococci and Lactobacilli with as effective as an anti-caries agent without staining the porous dental tissues black, as does silver diamine fluoride (SDF) and amalgam. NSF is low in cost substance and available as a yellow solution that proves to be stable for 3 years (64). SDF has been shown to be more effective than fluoride varnish (63).…”

Custo-eficácia do diamino fluoreto de prata a 30% no controle da progressão de lesões de cárie em esmalte na oclusão de molares em erupção: estudo clínico controlado e radomizado

“…Baseado nesse princípio, alguns estudos em Odontologia têm sido delineados utilizando um grupo controle em que o placebo seja utilizado (12,28,29). Nem sempre os produtos odontológicos a serem testados permitem que seus placebos os reproduzam em todas as características, que seria necessário para um placebo ideal (24).…”