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 |
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Participants | Participants: mean age 31 years Total number: 30 Inclusion criteria:
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 |
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Interventions | Total number of intervention groups: 3 10% carbamide peroxide tray 17% carbamide peroxide tray 0% carbamide peroxide tray Duration of treatment: 7 days |
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Outcomes | Pain sensation Patient contentment with bleaching: 0 no contentment, 100 maximum contentment |
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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 |
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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 |