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

Tsubura 2005.

Methods Title: clinical evaluation of a new bleaching product Polanight in a Japanese population
Trial design: split‐mouth, randomised controlled trial
Location: private dental clinic
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: SDI Ltd
Participants Participants: 18 to 47 years old. Mean age 30 years
Total number: 58
Inclusion criteria: not reported
Exclusion criteria: not reported
Number randomised: 58
Method of randomisation: not reported
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 58
Interventions Total number of intervention groups: 2
Polanight: 10% carbamide peroxide
Opalescence: 10% carbamide peroxide
Duration of treatment: 2 weeks
Outcomes Improvement in tooth colour
ΔL, a*, b* values: increase in ΔL and decrease in b* indicates lightening of teeth
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "Treatment with either agent demonstrated significant bleaching effects produced by the treatment. Bleaching with PN was considered more effective than that with OP in the young patient group and in the women"
Correspondence required: no
Contact: R Yamaguchi, hshimo@ngt.ndu.ac.jp
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...were randomly selected from the patients visiting." However, method of randomisation is not described
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None