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

Costa 2012.

Methods Title: comparison of 2 at‐home whitening products of similar peroxide concentration and different delivery methods
Trial design: randomised, single‐blinded, split‐mouth design
Location: not reported
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Ultradent
Participants Participants: 21 to 75 years old
Total number: 25
Inclusion criteria:
  • be at least 18 years old

  • willing to sign a consent form

  • willing to return for post‐whitening evaluation

  • presence of all 6 maxillary teeth equal or darker than 1M2 VITA bleached guide in the value

  • have no maxillary anterior teeth with more than 1/6 of the facial surface covered with a restoration


Exclusion criteria:
  • history of any medical disease that may interfere with the study or require special consideration

  • presence of gross pathology

  • use of tobacco products during previous 30 days

  • current or previous use of whitening agent

  • Loë and Silness 29 gingival score > 1.0

  • pregnant or lactating women

  • tetracycline‐stained teeth


Number randomised: 25
Method of randomisation: not reported
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 24
Interventions Total number of intervention groups: 2
35% carbamide peroxide
14% hydrogen peroxide
Duration of treatment: 2 weeks
Outcomes Improvement in tooth shade: a*. b* and L were recorded. Whitening benefit was represented by negative b (yellowness reduction), and positive ΔL (increasing lightness)
Sensitivity: VAS scale: 1 no pain, 10 severe pain
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "There was no significant difference in tooth colour change between carbamide peroxide and hydrogen peroxide at either time point. By the end of the study no participants reported tooth and gingival sensitivity. Participants preferred CP over HP"
Contact: Dr D Costa; dacostaj@ohsu.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomised, single‐blinded, split‐mouth design clinical study." 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, single‐blinded, split‐mouth design clinical study." However, method is not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "randomised, single‐blinded, split‐mouth design clinical study." However, method is not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "A total of 25 participants enrolled and 24 completed the study"
Comment: 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