Kose 2011.
Methods | Title: clinical effects of at‐home bleaching along with desensitizing agent application Trial design: randomised, double‐blinded, controlled trial Location: University Estadua, Brazil Language: English Number of centres: 1 Recruitment period: not reported Funding source: FGM Dental Products |
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Participants | Participants: 18 to 30 years old. Mean age 24 years Total number: 60 Inclusion criteria:
Exclusion criteria:
Number randomised: 60 Method of randomisation: coin toss Method of allocation concealment: not reported Method of blinding: similar syringes Number evaluated: 60 |
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Interventions | Total number of intervention groups: 2 16% carbamide peroxide in tray + placebo 16% carbamide peroxide in tray + desensitizer gel (DG; 5% potassium nitrate and 2% sodium fluoride) Duration of treatment: 4 weeks |
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Outcomes | Improvement in tooth shade: Vita shade guide B1 (highest) to C4 (lowest) Tooth sensitivity: 0 ‐ none, 1 – mild, 2 ‐ moderate, 3 ‐ considerable, 4 ‐ severe |
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Notes | Sample size calculation: not reported Adverse effects: tooth sensitivity Health‐related quality of life: not reported Key conclusions of the study authors: "The use of desensitizing agent did not affect the bleaching efficacy of the CP. The prevalence and intensity of tooth sensitivity was similar for both groups. However, participants from the placebo group had sensitivity in 33.6% of the bleaching days, which was significantly higher than the desensitizing agent experimental group (20.1%)" Correspondence required: no Contact: Dr Kose, School of Dentistry, State University of Ponda, Santa Catarina, Brazil |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "subjects were randomly divided into experimental or control group by coin toss" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Neither the subjects nor the evaluators knew to which group the subjects were assigned" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Neither the subjects nor the evaluators knew to which group the subjects were assigned" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All 60 participants who began study completed the study" |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |