Meireles 2010.
Methods | Title: double‐blinded randomised clinical trial of 2 carbamide peroxide tooth bleaching agents: 2‐year follow‐up Trial design: double‐blinded, randomised clinical trial Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: not reported |
|
Participants | Participants: not reported Total number: 183 Inclusion criteria:
Exclusion criteria:
Number randomised: 92 Method of randomisation: randomisation table Method of allocation concealment: not reported Method of blinding: labels were removed Number evaluated: 91 |
|
Interventions | Total number of intervention groups: 2 Control: carbamide peroxide 10% in tray Experimental: carbamide peroxide 16% in tray Duration of treatment: 2 hours per day for 3 weeks |
|
Outcomes | Improvement in tooth shade: ΔL, a*, b* values recorded Oral impact on daily performance (OIDP) 0 = no sensitivity; 1 = mild sensitivity; 2 = moderate sensitivity; 3 = considerable sensitivity and 4 = severe sensitivity The self‐reported general health was based on a Likert scale: excellent; very good; good; regular; bad (latter categorized in excellent/very good and good/regular) |
|
Notes | Sample size calculation: mentioned Adverse effects: tooth sensitivity Health‐related quality of life: reported Key conclusions of the study authors: "The whitening effect evaluated by visual shade matching and digital spectrophotometer remained similar after 6 months of bleaching treatment using any of the carbamide peroxide concentrations tested. Additionally, the high consumption of staining beverage and food had no influence in the whitening effect longevity. Quality of life is complex and encompasses different domains. Although positive impact of the dental bleaching was detected, with patients showing more their teeth without embarrassment, difficult in dental hygiene and pain resulting from the treatment were also reported, and this can negatively impact daily performances. Dentists must consider these aspects when performing aesthetics procedures" This is a 2‐year follow‐up report of the previous study Correspondence required: no Contact: SS Meireles; soniasaeger@hotmail.com |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A randomisation table to allocate the participants in each study...." |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The product concentration label was removed, therefore, the examiners and participants were blinded to the agent" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 dropout. Plausible effect size (difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |