Gerlach 2002b.
Methods | Title: comparative response of whitening strips to a low peroxide and potassium nitrate bleaching gel Trial design: randomised, examiner‐blinded clinical trial. 2 arms Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: Procter & Gamble |
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Participants | Participants: mean age of 37 years Total number: 34 Inclusion criteria: be willing to have their teeth whitened Exclusion criteria:
Number randomised: 34 Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not repeated Number evaluated: 32 |
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Interventions | Total number of intervention groups: 2 5% carbamide peroxide bleaching gel + potassium nitrate in custom tray: once daily application 6% hydrogen peroxide bleaching strip: twice daily application Duration of treatment: 7 days |
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Outcomes | Improvement in tooth shade ΔL, a*, b* were recorded. Increase in ΔL and decrease in b* indicates whitening |
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Notes | Sample size calculation: not reported Adverse effects: tooth sensitivity and oral irritation Health‐related quality of life: not reported Key conclusions of the study authors: "Twice daily application of 6% hydrogen peroxide strip resulted in better whitening compared to 1 daily application of 5% carbamide peroxide. Sensitivity was less with 6% hydrogen peroxide" Contact: gerlach.rw@pg.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Study subjects were randomly assigned to 1 of 2 groups." However, method is not reported |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "randomised examiner‐blinded clinical study." However, method is not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "randomised examiner‐blinded clinical study." However, method is not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 subjects missed the day 7 visit" Comment: 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 |