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

Kose 2011.

Methods Title: clinical effects of at‐home bleaching along with desensitizing agent application
Trial design: randomised, double‐blinded, controlled trial
Location: University Estadua, Brazil
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: FGM Dental Products
Participants Participants: 18 to 30 years old. Mean age 24 years
Total number: 60
Inclusion criteria:
  • 18 and older

  • 6 caries and restoration free teeth

  • A2 shade or darker


Exclusion criteria:
  • previous vital bleaching, apparent caries, periodontal disease

  • orthodontic appliances, anterior restorations

  • history of dentine hypersensitivity

  • bruxism


Number randomised: 60
Method of randomisation: coin toss
Method of allocation concealment: not reported
Method of blinding: similar syringes
Number evaluated: 60
Interventions Total number of intervention groups: 2
16% carbamide peroxide in tray + placebo
16% carbamide peroxide in tray + desensitizer gel (DG; 5% potassium nitrate and 2% sodium fluoride)
Duration of treatment: 4 weeks
Outcomes Improvement in tooth shade: Vita shade guide B1 (highest) to C4 (lowest)
Tooth sensitivity: 0 ‐ none, 1 – mild, 2 ‐ moderate, 3 ‐ considerable, 4 ‐ severe
Notes Sample size calculation: not reported
Adverse effects: tooth sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "The use of desensitizing agent did not affect the bleaching efficacy of the CP. The prevalence and intensity of tooth sensitivity was similar for both groups. However, participants from the placebo group had sensitivity in 33.6% of the bleaching days, which was significantly higher than the desensitizing agent experimental group (20.1%)"
Correspondence required: no
Contact: Dr Kose, School of Dentistry, State University of Ponda, Santa Catarina, Brazil
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "subjects were randomly divided into experimental or control group by coin toss"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Neither the subjects nor the evaluators knew to which group the subjects were assigned"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Neither the subjects nor the evaluators knew to which group the subjects were assigned"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "All 60 participants who began study completed the study"
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None