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. 2018 Dec 18;2018(12):CD006202. doi: 10.1002/14651858.CD006202.pub2

Auschill 2012.

Methods Title: randomised clinical trial of the efficacy, tolerability, and long‐term colour stability of 2 bleaching techniques: 18‐month follow‐up
Trial design: 2‐cell, parallel, examiner‐blinded, randomised controlled trial
Location: Albert‐Ludwigs‐University, Freiburg, Germany
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Colgate Palmolive
Participants Participants: 18 to 56 years old, mean age: 33.08 years
Total number: 30
Inclusion criteria:
  • maxillary central incisor with A3 or darker shade

  • free of restorations

  • no prior bleaching


Exclusion criteria:
  • fixed orthodontic appliance

  • tooth hypersensitivity


Number randomised: 30
Method of randomisation: a computer‐based randomisation
Method of allocation concealment: not reported
Method of blinding: personal examiner blinding done by coding which was only known to statistician
Number evaluated: 28. 2 dropouts at follow‐up
Interventions Total number of intervention groups: 2
Tray group: 5% hydrogen peroxide
Strip group: 5.3% hydrogen peroxide
Duration of treatment: 14 days
Outcomes Improvement in tooth shade
Vita shade guide: ranked from lightest B1 (1) to darkest C4 (16); mean score for anterior teeth was calculated
Adverse effects. Patient recorded: mild, moderate and severe
Patient acceptance, gingival irritation, sensitivity
VAS scale: 0 (best acceptance) to 10 (no acceptance)
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Key conclusions of the study authors: "Both bleaching techniques (the tray technique with 5.0% hydrogen peroxide and the strip technique with 5.3% hydrogen peroxide) demonstrated similar success. Although a significant relapse in tooth shade was observed over an 18‐month post bleaching period, treated teeth were still significantly lighter compared to baseline. Adverse effects were minimal and reversible. Patient acceptance was statistically significantly higher in the tray group compared with the strip group"
Correspondence required: no
Contact: Dr Thorsten M Auschill; auschill@med.uni‐marburg.de
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer‐based randomisation scheme (generated before starting the study) allocated patients…"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "2‐cell, parallel, examiner‐blinded, randomised controlled trial." However, method is not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "..examiners, who were blinded to the treatment modality and period, subjectively measured.. Personal blinding done by coding which was only known to statistician"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "2 had to be classified as dropouts for that single visit. Thus, 28 subjects were available at the 18‐month follow‐up"
Comment: as each group had 14 participants each we considered it as low risk according to Higgins 2011 Section 8.5.d. Missing outcome data balanced in numbers across intervention groups
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None