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

Gerlach 2005.

Methods Title: clinical trial comparing 2 hydrogen peroxide tooth whitening systems: strips versus pre‐rinse
Trial design: randomised, examiner‐blinded, parallel‐group trial
Location: not reported
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Procter & Gamble
Participants Participants: 29 to 58 years old. Mean age 39.8 years
Total number: 28
Inclusion criteria:
  • 4 maxillary anterior teeth

  • no sensitivity


Exclusion criteria: not reported
Number randomised: 28
Method of randomisation: not reported
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 28
Interventions Total number of intervention groups: 2
Mouthwash: 2% hydrogen peroxide
Strip: 10% hydrogen peroxide
Duration of treatment: 7 days
Outcomes Improvement in tooth shade
a*, b* and ΔL were recorded
Whitening benefit was represented by negative b* (yellowness reduction), and positive ΔL (increasing lightness)
Notes Sample size calculation: not reported
Adverse effects: tooth sensitivity and oral irritation
Health‐related quality of life: not reported
Key conclusions of the study authors: "Relative to baseline, the whitening strip group experienced colour improvement at day 3, continuing through day 8. The pre‐rinse group did not show any significant change at day 3, and had a significant increase in yellowness at day 8. The strip group exhibiting significantly greater whitening at day 8. Both products were well tolerated, with no participants discontinuing treatment early as the result of an adverse event. In head‐to‐head testing, 7‐day use of the 10% hydrogen peroxide whitening strips resulted in significant tooth colour improvement relative to a barrier‐free 2% hydrogen peroxide pre‐brushing mouthrinse"
Correspondence required: no
Contact: Dr Geralch; geralch.rw@pg.com
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...subjects were randomly assigned to 1 of 2 test groups." However, method of randomisation is not mentioned
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Examiner‐blinded, parallel‐group, randomised controlled trial." However, method of blinding not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Examiner‐blinded, parallel‐group, randomised controlled trial." However, method of blinding not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "All the participants completed all the visits and were evaluated"
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None