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

Krause 2008.

Methods Title: subjective intensities of pain and contentment with treatment outcomes during tray bleaching of vital teeth employing different carbamide peroxide concentrations
Trial design: double‐blinded, randomised controlled trial
Location: university
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: not reported
Participants Participants: mean age 31 years
Total number: 30
Inclusion criteria:
  • patients with teeth not discoloured for extrinsic or intrinsic reasons

  • non‐smokers


Exclusion criteria: not reported
Number randomised: 30
Method of randomisation: computer generated numbers
Method of allocation concealment: not reported
Method of blinding: unlabelled similar packs
Number evaluated: 30
Interventions Total number of intervention groups: 3
10% carbamide peroxide tray
17% carbamide peroxide tray
0% carbamide peroxide tray
Duration of treatment: 7 days
Outcomes Pain sensation
Patient contentment with bleaching: 0 no contentment, 100 maximum contentment
Notes Sample size calculation: not reported
Adverse effects: not reported
Health‐related quality of life: yes, patient satisfaction
Key conclusions of the study authors: "Application of carbamide peroxide–containing bleaching agents to vital teeth causes pain correlated with the
agent's concentration. Since both highly and less concentrated gels might result in a similar contentment with the treatment outcome, the use of highly concentrated agents appears not to be justified to improve vital tooth colour"
Contact: Felix Krause, fkrause@uni‐bonn.de
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "kits were assigned to the patients employing computer‐generated random numbers by a different operator"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Unlabelled treatment kits numbered consecutively. Thus, both the operator and the patient were unaware of the..."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Unlabelled treatment kits numbered consecutively. Thus, both the operator and the patient were unaware of the..."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants completed the study
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None