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

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
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
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
Outcomes Tooth sensitivity
Tooth whitening: patient‐reported improvement
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
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