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

Navarra 2014.

Methods Title: effects of 2 10% carbamide peroxide Nightguard bleaching agents, with and without desensitizer, on enamel and sensitivity: an in vivo study
Trial design: blinded, randomised controlled trial
Location: not reported
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: supported, in part, by grants from MIUR (Italy)
Participants Participants: 20 to 50 years old. Mean age 25.3 years
Total number: 80
Inclusion criteria: not reported
Exclusion criteria:
  • smoking, pregnancy or breastfeeding

  • history of previous bleaching treatment

  • dentine hypersensitivity caused by caries lesions

  • fracture of restorations, chipped teeth, marginal gaps, post‐operative sensitivity

  • teeth with cervical fillings, and recent use of desensitizing toothpaste


Number randomised: 20
Method of randomisation: not reported
Method of allocation concealment: reported
Method of blinding: not reported
Number evaluated: 20
Interventions Total number of intervention groups: 2
10% carbamide peroxide with fluoride and potassium nitrate in tray
10% carbamide peroxide without desensitizing agents in tray
Duration of treatment: 2 weeks
Outcomes Improvement in tooth colour
ΔL, a*, b*, ΔW values were recorded. Increase in ΔL and reduction in b* indicated whitening
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Key conclusions of the study authors: "The use of 10% carbamide peroxide gel with fluoride and potassium nitrate reduced the incidence of sensitivity during the bleaching treatment compared to a bleaching agent that did not contain desensitizing agents. The bleaching effectiveness of the tested products was comparable"
Correspondence required: no
Contact: M Cadenaro, m.cadenaro@fmc.units.it
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "An operator not involved in the research protocol performed the randomisation." However, method of randomisation is not reported
Allocation concealment (selection bias) Low risk Quote: "allocated groups were recorded on cards contained in sequentially numbered, sealed envelopes that were blindly assigned"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "blinded randomised controlled trial." However, method of blinding is not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "blinded randomised controlled trial." However, method of blinding is not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None