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

Barnes 1998.

Methods Title: clinical evaluation of a new 10% carbamide peroxide tooth‐whitening agent
Trial design: double‐blinded clinical trial
Location: University of Maryland Dental School, USA
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Dentsply
Participants Participants: 18 to 65 years
Total number: 61
Inclusion criteria: A3 or darker shade
Exclusion criteria: not reported
Number randomised: not reported
Method of randomisation: not reported
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 50
Interventions Total number of intervention groups: 2 groups
10% carbamide peroxide gel in tray
Placebo
Duration of treatment: 4 hours to overnight for 2 weeks
Outcomes Improvement in tooth shade: 2 weeks, 3 months and 6 months
Tooth sensitivity
Gingival irritation
Notes Sample size calculation: not reported
Adverse effects: sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "The average shade change for the placebo users was less than 1 shade. The average shade change for the NUPRO Gold users was 6.96 shades. Tooth hypersensitivity varied from none to severe. Tissue irritation was minimal. The results of these evaluations indicate that NUPRO Gold is effective as a tooth whitening system, when administered properly under the supervision of a dentist, with commonly reported side effects of transient tooth sensitivity and minimal gingival sensitivity. Little or no change in tissue health was noted"
Correspondence required: yes: unclear if it is a randomised controlled trial. Authors have been mailed requesting for the data
Contact: Dr Douglas Barnes, University of Maryland, Maryland, USA