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

Nathoo 2002.

Methods Title: efficacy of novel, non‐tray paint on 18% carbamide peroxide gel
Trial design: double‐blinded, parallel‐group, randomised trial
Location: Colgate Palmolive Research Centre, USA
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Colgate Palmolive
Participants Participants: 18 to 58 years old. Mean age 39.79 years
Total number: 80
Inclusion criteria:
  • A3 shade or darker


Exclusion criteria:
  • orthodontic treatment

  • restoration or crowns


Number randomised: not reported
Method of randomisation: method not reported
Method of allocation concealment: method not reported
Method of blinding: non‐removable white packing with patient identification number
Number evaluated: 77
Interventions Total number of intervention groups: 2
18% carbamide peroxide paint‐on gel
Placebo
Duration of treatment: 21 days
Outcomes Change in tooth shade
Vita shade guide arranged base on lightness: 1 lightest (C1) to 16 darkest (B4)
Notes Sample size calculation: not reported
Adverse effects: not reported
Health‐related quality of life: not reported
Key conclusions of the study authors: "Study showed that subjects' teeth in the liquid whitening gel‐treated group exhibited an overall improvement and a 3.5‐shade difference compared with teeth in the placebo gel group. No soft tissue adverse reaction were reported"
Contact: Saleem A Nathoo, Colgate Palmolive Research Centre, Piscataway, New Jersey, USA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Qualifying subjects were then stratified... and randomly assigned within strata to one of the study treatment groups.." However, the method by which randomisation was done is not mentioned in the article
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "For blinding, all products were overwrapped with a non‐removable white label containing a unique subject identification number"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Number of patients randomised were 80. However, there were 3 dropouts.
Quote: "Subjects who did not complete the study dropped out for reasons unrelated to the use of the treatments or adverse events"
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 mentioned are reported adequately. Conclusion conforms to results
Other bias Low risk None