title: Tooth whitening with hydrogen peroxide in adolescents: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Technological innovations in dental materials have been fueled by the desire of patients to improve the esthetics of their teeth. This emphasis on esthetics has led dentists to seek resources that respect the standards established by society, but without compromising the integrity of the teeth.
  
  
  METHODS
  The aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with 6% and 7.5% hydrogen peroxide using home kits with whitening strips. Adolescents aged 12 to 20 years will be allocated to different groups based on treatment (n = 16 per group): (1) placebo; (2) 6.0% hydrogen peroxide (White Class with Calcium, FGM); (3) 7.5% hydrogen peroxide (White Class with Calcium, FGM); and (4) 7.5% hydrogen peroxide (Oral B 3D White, Oral-B). After the whitening procedures, the participants will be evaluated using a visual analog scale for tooth sensitivity and digital spectrophotometry to measure changes in color. Descriptive analysis of the data will be performed. Either the chi-squared test or Fisher's exact test will be used for the determination of associations among the categorical variables. Student's t-test and analysis of variance will be used to compare mean colorimetric data. Pearson's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables.
  
  
  CONCLUSIONS
  This randomized trial will provide an opportunity to evaluate products such as whitening strips in comparison to other self-administered methods, especially in adolescents.
  
  
  BACKGROUND
  The protocol for this study was submitted to Clinical Trials in November 2013 with registration number NCT01998386.
authors.forename: Marcelo Mendes
authors.initials: MM
authors.lastname: Pinto
authors.forename: Camila Haddad Leal
authors.initials: CH
authors.lastname: de Godoy
authors.forename: Carolina Carvalho
authors.initials: CC
authors.lastname: Bortoletto
authors.forename: Silvia Regina Garcia
authors.initials: SR
authors.lastname: Olivan
authors.forename: Lara Jansiski
authors.initials: LJ
authors.lastname: Motta
authors.forename: Olga Maria
authors.initials: OM
authors.lastname: Altavista
authors.forename: Katia
authors.initials: K
authors.lastname: Lumi
authors.forename: Ana Paula Taboada
authors.initials: AP
authors.lastname: Sobral
authors.affiliation: Universidade Nove de Julho (UNINOVE), R, Vergueiro, 235 - Liberdade, São Paulo SP CEP 01504-001, Brazil. sandra.skb@gmail.com.
authors.forename: Sandra Kalil
authors.initials: SK
authors.lastname: Bussadori
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001938:Brazil; D016009:Chi-Square Distribution; D002648:Child; D002985:Clinical Protocols; D005260:Female; D005782:Gels; D006801:Humans; D006861:Hydrogen Peroxide / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010147:Pain Measurement; D012107:Research Design; D013997:Time Factors; D014073:Tooth Bleaching / Q000009:adverse effects / Q000379:methods*; D058205:Tooth Bleaching Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014075:Tooth Discoloration / Q000175:diagnosis / Q000628:therapy*; D014098:Toothache / Q000139:chemically induced / Q000175:diagnosis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005782:Gels; D058205:Tooth Bleaching Agents; D006861:Hydrogen Peroxide