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. 2018 Dec 18;2018(12):CD006202. doi: 10.1002/14651858.CD006202.pub2

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
Participants Participants: age not reported
Total number: 65
Inclusion criteria:
  • 21 years of age and above

  • A3 or darker on vita shade guide


Exclusion criteria:
  • persons with significant medical problems or needing antibiotic premedication

  • pregnant or nursing women

  • persons with active dental caries or periodontal disease

  • persons with a history of vital bleaching

  • tetracycline staining


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
Interventions Total number of intervention groups: 2
3% hydrogen peroxide Nightguard gel
Placebo
Duration of treatment: 2 weeks
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
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
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