Tam 2001.
Methods | Title: effect of potassium nitrate and fluoride on carbamide peroxide bleaching Trial design: split‐mouth, double‐blinded, randomised clinical trial Location: University of Toronto, Canada Language: English Number of centres: 1 Recruitment period: not reported Funding source: not reported |
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Participants | Participants: 20 to 53 years old with a mean age of 31 (10) years Total number: 42 Inclusion criteria: not reported Exclusion criteria: no previous history of desensitizing agents Number randomised: not reported Method of randomisation: not reported Method of allocation concealment: syringes were randomly numbered and selected for use Method of blinding: identical packs Number evaluated: 40 |
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Interventions | Total number of intervention groups: 2 10% carbamide peroxide with 3% potassium nitrate and 0.11 fluoride ion wt/vol 10% carbamide peroxide Duration of treatment: 2 weeks |
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Outcomes | Tooth sensitivity Tooth whitening: patient‐reported improvement |
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Notes | Sample size calculation: not reported Adverse effects: sensitivity Key conclusions of the study authors: "A 10% carbamide peroxide bleaching gel containing potassium nitrate and fluoride produced less tooth sensitivity than did the control bleaching gel during a 2‐week at‐home bleaching treatment" Correspondence required: no Contact: Dr Laura Tam, laura.tam@utotonto.ca |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "double‐blinded randomised clinical trial." However, method of randomisation is not reported |
Allocation concealment (selection bias) | Unclear risk | Quote: "syringes were randomly numbered and selected for use on either the left or right side of each patient's dental arch" Comment: we are not sure if the person allocating the participants and the person conducting the study are the same |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "formulations were manufactured specifically for this study (Ultradent) and were packaged identically for..." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blinded randomised clinical trial." However, method of blinding is not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "1 patient chose to discontinue treatment .... A total of 9 treatment days (out of a potential total of 294 treatment days) were missed by the patients, either because of general tooth sensitivity or for personal reasons" Comment: no clear mention of dropouts in the article |
Selective reporting (reporting bias) | Low risk | All outcomes discussed have been reported adequately. Conclusions are in accordance with the results |
Other bias | Low risk | None |