In-vivo durability of a fluoride-releasing sealant (OpalSeal) for protection against white-spot lesion formation in orthodontic patients

BACKGROUND Sealant application during fixed appliances orthodontic treatment for enamel protection is common, however, reliable data on its durability in vivo are rare. OBJECTIVE This study aims at assessing the durability of a sealant (OpalSeal, Ultradent) for protection against white-spot lesion formation in orthodontic patients over 26 weeks in vivo, taking into account the provision or absence of an adequate oral hygiene. We tested the null hypothesis of (1) no significant abatement of the sealant after 26 weeks in fixed orthodontic treatment compared to baseline, and (2) no significant influence of the factor of brushing and oral hygiene (as screened by approximal plaque index, API) on the abatement of the sealant. METHODS Integrity and abatement of OpalSeal applicated directly following bracketing was assessed in thirty-six consecutive patients (n(teeth) = 796) undergoing orthodontic treatment with fixed appliances (male/female 12/24; mean age/SD 14.4/1.33 Y). Assessment of the fluorescing sealant preservation was by a black-light lamp, using a classification that was concepted in analogy to the ARI index: (3, sealant completely preserved; 2= > 50% preserved; 1 = <50%; 0 = no sealant observable) immediately following application (Baseline, T0), after 2 (T1), 8 (T2), 14 (T3), 20 (T4) and 26 weeks (T5). API was assessed at T0 and T1. Statistical analysis was by non-parametric repeated measures ANOVA (α = 5%, power >80%). RESULTS At baseline, 43.4% of teeth had a positive API. Oral hygiene deteriorated after bracketing (T1, 53%) significantly. Null hypothesis (1) was rejected, while (2) was accepted: Mean values of both the well brushed and non-brushed anterior teeth undercut the score "1" at T3 (week 14). Despite a slightly better preservation of the sealer before and after T3 in not-sufficiently brushed (API-positive) teeth, this finding was statistically not significant. CONCLUSION One single application of OpalSeal is unlikely to last throughout the entire fixed appliance treatment stage. On average, re-application of the sealant can be expected to be necessary after 3.5 months (week 14) in treatment.