Myers 2003.
Methods | Title: clinical evaluation of a 3% hydrogen peroxide tooth whitening gel Trial design: double‐blinded, placebo‐controlled, randomised trial Location: School of Dentistry, Medical College of Georgia, Augusta, Georgia, USA Language: English Number of centres: 1 Recruitment period: not reported Funding source: Applied Dental Sciences |
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Participants | Participants: age not reported Total number: 65 Inclusion criteria:
Exclusion criteria:
Number randomised: 65 Method of randomisation: randomisation table by statistician Method of allocation concealment: syringes were labelled with the participant number. A single labelled syringe of gel was retained from each participant's box for later testing if needed Method of blinding: not reported Number evaluated: 65 |
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Interventions | Total number of intervention groups: 2 3% hydrogen peroxide Nightguard gel Placebo Duration of treatment: 2 weeks |
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Outcomes | Colour change: Vita shade guide arranged base on lightness: 1 lightest (C1) to 16 darkest (B4) Dental sensitivity Irritation to tongue, gingiva, and throat |
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Notes | Sample size calculation: not reported Adverse effects: sensitivity in tongue and gingiva, dental sensitivity to hot and cold Health‐related quality of life: not reported Key conclusions of the study authors: "Patient‐applied NGVB with a 3% hydrogen peroxide gel for 30 minutes 3 times a day for 2 weeks was effective in whitening teeth an average of 4.2 Vita shade tabs. The lightening effect was maintained at 6 months, and the side effects with this agent were similar to other whitening agents. The use of this material could be considered for patients who cannot comply with the regimen" Contact: Michael L Myers, Department of Oral Rehabilitation, School of Dentistry, Medical College of Georgia, Augusta, Georgia 3091 USA; mmyers@mail.mcg.edu |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A randomisation table was prepared by the lead statistician (CMR), who also maintained participant identification numbers used throughout the study" |
Allocation concealment (selection bias) | Low risk | Quote: "A randomisation table was prepared by the lead statistician (CMR), who also maintained participant identification numbers used throughout the study..... The outside of the box and the individual syringes were labelled with the paticipant number" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blinded study but method of blinding not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blinded study but method of blinding not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported |
Selective reporting (reporting bias) | Low risk | All outcomes described were reported. Conclusions are in accordance with the results |
Other bias | Low risk | None |