title: In-vivo durability of a fluoride-releasing sealant (OpalSeal) for protection against white-spot lesion formation in orthodontic patients.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Orthodontics, University Medical Center Göttingen (UMG), 37099, Göttingen, Germany. mknoesel@yahoo.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Knösel
authors.affiliation: Department of Medical Statistics, University Medical Center Göttingen (UMG), 37099, Göttingen, Germany. David.Ellenberger@med.uni-goettingen.de.
authors.forename: David
authors.initials: D
authors.lastname: Ellenberger
authors.affiliation: Private Practice, Hannover, Germany. yvonnegoeldner@gmx.de.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Göldner
authors.affiliation: Department of Orthodontics, Universidad de la Frontera (UFRO), Temuco, Chile. ortodonciadrsandoval.temuco@gmail.com.
authors.forename: Paulo
authors.initials: P
authors.lastname: Sandoval
authors.affiliation: Orthodontic Practice, Lindenstrasse 44, 49152 Bad, Essen, Germany. wiechmann@dw-consulting.de.|Department of Orthodontics, Hannover Medical School (MHH), 30625, Hannover, Germany. wiechmann@dw-consulting.de.
authors.forename: Dirk
authors.initials: D
authors.lastname: Wiechmann
mesh_terms: D000293:Adolescent; D003774:Dental Plaque Index; D019232:Dental Restoration Failure; D005260:Female; D005459:Fluorides / Q000378:metabolism*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008422:Materials Testing; D008991:Monitoring, Physiologic / Q000379:methods; D009910:Oral Hygiene; D016910:Orthodontic Brackets / Q000009:adverse effects*; D009971:Orthodontics, Corrective / Q000379:methods; D010895:Pit and Fissure Sealants / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry; D018570:Risk Assessment; D013718:Tensile Strength; D017001:Tooth Demineralization / Q000209:etiology / Q000517:prevention & control*
chemical_list: D010895:Pit and Fissure Sealants; D005459:Fluorides