title: Clinical response of three whitening products having different peroxide delivery: comparison of tray, paint-on gel, and dentifrice.
abstract: OBJECTIVE
  Comparative clinical research was conducted to evaluate the efficacy and safety of three peroxide-containing tooth whitening products having different peroxide delivery.
  
  
  METHODS
  A total of 43 healthy adults who met entrance criteria were randomly assigned to either a dual-phase, anticavity, 1% hydrogen peroxide dentifrice with a manganese gluconate activator, an 18% carbamide peroxide paint-on gel, or a 5% carbamide peroxide professional custom tray system. Following manufacturer's instructions, the activated dentifrice was used at least twice daily for two minutes, while the paint-on gel was applied twice daily. The custom tray, a barrier system and the experimental control for this study, was worn continuously for six to eight hours daily. Tooth color (L*a*b*) was measured on the maxillary anterior teeth from standard digital images, while safety was assessed from examination and subject report.
  
  
  RESULTS
  At Day 15, the custom tray group had a significant (p < 0.002) reduction in yellowness and increased lightness, with adjusted mean (SE) deltab* of -1.83 (0.210) and deltaL* of 1.45 (0.292). The custom tray group experienced on average greater color improvement compared to either the paint-on gel or activated peroxide whitening dentifrice, differing significantly (p < 0.01) from either of the barrier-free systems with respect to deltab*, deltaL*, deltaE*, and deltaW*. In comparison, 14-days' use of the paint-on gel and activated dentifrice did not result in significant (p > 0.10) color improvements from baseline for deltab*, deltaL*, or deltaW*, with these two barrier-free systems not differing significantly (p > 0.26) with respect to any individual or composite color parameters. Tooth sensitivity and oral irritation were the most common safety findings in the tray and dentifrice groups (there were no adverse events in the paint-on group), and no subject discontinued treatment early because of a treatment-related adverse event.
  
  
  CONCLUSIONS
  In head-to-head 14-day testing, a low concentration (5% carbamide peroxide) barrier-based tray system yielded superior tooth color improvement compared to two barrier-free delivery systems-an 18% carbamide peroxide paint-on gel and a 1% hydrogen peroxide dentifrice with a metal activator.
authors.affiliation: The Procter & Gamble Company, Health Care Research Center, Mason, OH, USA. gerlach.rw@pg.com
authors.forename: Robert W
authors.initials: RW
authors.lastname: Gerlach
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Barker
authors.forename: Heidi L
authors.initials: HL
authors.lastname: Tucker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000077463:Carbamide Peroxide; D003116:Color; D003481:Cuspid / Q000033:anatomy & histology; D003802:Dentifrices / Q000627:therapeutic use*; D003807:Dentin Sensitivity / Q000139:chemically induced; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D006861:Hydrogen Peroxide / Q000008:administration & dosage / Q000627:therapeutic use*; D007180:Incisor / Q000033:anatomy & histology; D008297:Male; D008875:Middle Aged; D016877:Oxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D010545:Peroxides / Q000008:administration & dosage / Q000627:therapeutic use*; D012449:Safety; D016037:Single-Blind Method; D013280:Stomatitis / Q000139:chemically induced; D014073:Tooth Bleaching / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014508:Urea / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D003802:Dentifrices; D004338:Drug Combinations; D005782:Gels; D016877:Oxidants; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea; D006861:Hydrogen Peroxide