Hyland 2015.
Methods | Title: a new 3‐component formulation for the efficient whitening of teeth (Carbamide Plus) Trial design: randomised, double‐blinded, placebo‐controlled, clinical trial Location: Eastman Dental Hospital, UK Language: English Number of centres: 1 Recruitment period: not reported Funding source: SMT Ltd and DEL CAST studentship |
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Participants | Participants: adults Total number: 33 Inclusion criteria: not reported Exclusion criteria:
Number randomised: 32 Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not reported Number evaluated: 32 |
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Interventions | Total number of intervention groups: 3 5% carbamide peroxide gel 10% carbamide peroxide gel Placebo Duration of treatment: 2 hours per day for 2 weeks |
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Outcomes | Improvement in tooth colour ΔL, a*, b*: increase in ΔL and reduction in b* indicates whitening |
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Notes | Sample size calculation: not reported Adverse effects: not reported Health‐related quality of life: not reported Key conclusions of the study authors: "A new tooth‐whitening product Carbamide Plus containing urea, hydrogen peroxide, and STPP as active components containing 5% hydrogen peroxide has been shown to be as effective as the commercially available carbamide peroxide containing 10% hydrogen peroxide. There were no statistically significant differences between Carbamide Plus and 10% carbamide peroxide in tooth whitening at 2 weeks following daily wear of tooth whitening trays for 2 hours per day" Correspondence required: no Contact: BW Hyland; j.callan@ulster.ac.uk |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The recruited subjects were randomly allocated to 1 of 3 study groupings: non‐active placebo gel..." However, method is not reported |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "randomised, double‐blinded, placebo‐controlled clinical trial." However, method is not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "randomised, double‐blinded, placebo‐controlled clinical trial." However, method 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 |