title: Placebo-controlled clinical trial of a 19% sodium percarbonate whitening film: initial and sustained whitening.
abstract: OBJECTIVE
  To evaluate in a randomized, double-blind, placebo-controlled clinical trial the initial, cumulative and sustained whitening with a brush-applied, peroxide-based, overnight tooth whitener.
  
  
  METHODS
  50 adults were randomized to Crest Night Effects, a 19% sodium percarbonate gel that dries to form an adherent film, or a placebo gel without any peroxide source. The treatments were brush-applied at night, and removed the next morning with normal toothbrushing. Subjects were evaluated biweekly during the 6-week treatment period to evaluate initial and cumulative color change, and again, 4 weeks after completion of treatment to evaluate color relapse. Efficacy was determined by evaluating reduction in tooth yellowness (delta b*), increase in tooth brightness (delta L*) and overall change relative to white (delta W*) from standardized digital images. Tolerability was assessed by examination and interview conducted at treatment and post-treatment visits.
  
  
  RESULTS
  Relative to baseline, the 19% sodium percarbonate film group had significantly (P < or = 0.013) whiter teeth after 2 weeks overnight use. For maxillary teeth, delta b* and delta L* means (SD) were: -1.35 (0.858) and 1.06 (0.886), respectively. For mandibular teeth, delta b* and delta L* means (SD) were: -1.27 (0.903) and 0.56 (0.790), respectively. Relative to placebo, the 19% sodium percarbonate group was significantly (P < 0.005) better than placebo for delta b*, delta L*, and delta W*. There was a cumulative benefit with additional treatment, as evidenced by significant (P < 0.0001) improvement in mean delta b* after the initial 2 weeks of treatment. Approximately 90% of the 6-week cumulative color improvement was still evident after 4 weeks post-treatment. Tooth sensitivity (20% of the peroxide group) represented the only adverse event with increased occurrence over placebo, and these events were mild and fully resolved during/after treatment.
authors.affiliation: Department of Periodontics, University of Florida, College of Dentistry, Gainesville, FL 32610, USA. kkarpinia@dental.ufl.edu
authors.forename: Katherine A
authors.initials: KA
authors.lastname: Karpinia
authors.forename: Ingvar
authors.initials: I
authors.lastname: Magnusson
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Barker
authors.forename: Robert W
authors.initials: RW
authors.lastname: Gerlach
mesh_terms: D000287:Administration, Topical; D000328:Adult; D002254:Carbonates / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D020034:Silicone Gels / Q000008:administration & dosage*; D014073:Tooth Bleaching / Q000379:methods*; D014075:Tooth Discoloration / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D002254:Carbonates; D020034:Silicone Gels; C034738:sodium percarbonate