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

Hyland 2015.

Methods Title: a new 3‐component formulation for the efficient whitening of teeth (Carbamide Plus)
Trial design: randomised, double‐blinded, placebo‐controlled, clinical trial
Location: Eastman Dental Hospital, UK
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: SMT Ltd and DEL CAST studentship
Participants Participants: adults
Total number: 33
Inclusion criteria: not reported
Exclusion criteria:
  • heavily restored upper left central incisor or upper right canine

  • pregnancy or breastfeeding

  • previously undergone a course of vital tooth whitening

  • smokers

  • active dental disease

  • severe dentine hypersensitivity

  • uncontrolled dental disease

  • unable to attend on data collection


Number randomised: 32
Method of randomisation: not reported
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 32
Interventions Total number of intervention groups: 3
5% carbamide peroxide gel
10% carbamide peroxide gel
Placebo
Duration of treatment: 2 hours per day for 2 weeks
Outcomes Improvement in tooth colour
ΔL, a*, b*: increase in ΔL and reduction in b* indicates whitening
Notes Sample size calculation: not reported
Adverse effects: not reported
Health‐related quality of life: not reported
Key conclusions of the study authors: "A new tooth‐whitening product Carbamide Plus containing urea, hydrogen peroxide, and STPP as active components containing 5% hydrogen peroxide has been shown to be as effective as the commercially available carbamide peroxide containing 10% hydrogen peroxide. There were no statistically significant differences between Carbamide Plus and 10% carbamide peroxide in tooth whitening at 2 weeks following daily wear of tooth whitening trays for 2 hours per day"
Correspondence required: no
Contact: BW Hyland; j.callan@ulster.ac.uk
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The recruited subjects were randomly allocated to 1 of 3 study groupings: non‐active placebo gel..." 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, double‐blinded, placebo‐controlled clinical trial." However, method is not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "randomised, double‐blinded, placebo‐controlled clinical trial." However, method 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