Navarra 2014.
Methods | Title: effects of 2 10% carbamide peroxide Nightguard bleaching agents, with and without desensitizer, on enamel and sensitivity: an in vivo study Trial design: blinded, randomised controlled trial Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: supported, in part, by grants from MIUR (Italy) |
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Participants | Participants: 20 to 50 years old. Mean age 25.3 years Total number: 80 Inclusion criteria: not reported Exclusion criteria:
Number randomised: 20 Method of randomisation: not reported Method of allocation concealment: reported Method of blinding: not reported Number evaluated: 20 |
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Interventions | Total number of intervention groups: 2 10% carbamide peroxide with fluoride and potassium nitrate in tray 10% carbamide peroxide without desensitizing agents in tray Duration of treatment: 2 weeks |
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Outcomes | Improvement in tooth colour ΔL, a*, b*, ΔW values were recorded. Increase in ΔL and reduction in b* indicated whitening |
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Notes | Sample size calculation: not reported Adverse effects: sensitivity Key conclusions of the study authors: "The use of 10% carbamide peroxide gel with fluoride and potassium nitrate reduced the incidence of sensitivity during the bleaching treatment compared to a bleaching agent that did not contain desensitizing agents. The bleaching effectiveness of the tested products was comparable" Correspondence required: no Contact: M Cadenaro, m.cadenaro@fmc.units.it |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "An operator not involved in the research protocol performed the randomisation." However, method of randomisation is not reported |
Allocation concealment (selection bias) | Low risk | Quote: "allocated groups were recorded on cards contained in sequentially numbered, sealed envelopes that were blindly assigned" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "blinded randomised controlled trial." However, method of blinding is not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "blinded randomised controlled trial." However, method of blinding is not reported |
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 |