Gerlach 2005.
Methods | Title: clinical trial comparing 2 hydrogen peroxide tooth whitening systems: strips versus pre‐rinse Trial design: randomised, examiner‐blinded, parallel‐group trial Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: Procter & Gamble |
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Participants | Participants: 29 to 58 years old. Mean age 39.8 years Total number: 28 Inclusion criteria:
Exclusion criteria: not reported Number randomised: 28 Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not reported Number evaluated: 28 |
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Interventions | Total number of intervention groups: 2 Mouthwash: 2% hydrogen peroxide Strip: 10% hydrogen peroxide Duration of treatment: 7 days |
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Outcomes | Improvement in tooth shade a*, b* and ΔL were recorded Whitening benefit was represented by negative b* (yellowness reduction), and positive ΔL (increasing lightness) |
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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: "Relative to baseline, the whitening strip group experienced colour improvement at day 3, continuing through day 8. The pre‐rinse group did not show any significant change at day 3, and had a significant increase in yellowness at day 8. The strip group exhibiting significantly greater whitening at day 8. Both products were well tolerated, with no participants discontinuing treatment early as the result of an adverse event. In head‐to‐head testing, 7‐day use of the 10% hydrogen peroxide whitening strips resulted in significant tooth colour improvement relative to a barrier‐free 2% hydrogen peroxide pre‐brushing mouthrinse" Correspondence required: no Contact: Dr Geralch; geralch.rw@pg.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...subjects were randomly assigned to 1 of 2 test groups." However, method of randomisation is not mentioned |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Examiner‐blinded, parallel‐group, randomised controlled trial." However, method of blinding not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "Examiner‐blinded, parallel‐group, randomised controlled trial." However, method of blinding not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All the participants completed all the visits and were evaluated" |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |