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

Botelho 2017.

Methods Title: a randomised controlled trial of home bleaching of tetracycline‐stained teeth
Trial design: randomised, examiner‐blinded controlled trial
Location: University of Hong Kong
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: not reported
Participants Participants: tray group: mean age 28.7 years; strip group: mean age 30.4 years
Total number: 36
Inclusion criteria:
  • tetracycline stained teeth

  • maxillary anterior teeth sound or minimally restored

  • able to attend 4‐month review


Exclusion criteria:
  • subjects under 18

  • medically unfit

  • pregnant or lactating

  • uncontrolled oral disease or infection

  • history of tooth whitening treatment

  • smoker

  • allergy to hydrogen peroxide or carbamide peroxide


Number randomised: 26
Method of randomisation: coin toss
Method of allocation concealment: not reported
Method of blinding: not reported
Number evaluated: 24 (2 dropouts (1 for each group) at follow‐up)
Interventions Total number of intervention groups: 2
Tray: 15% carbamide peroxide
Strip: 6.5% hydrogen peroxide
Duration of treatment: 3 months
Outcomes Improvement in tooth colour
a*, b* and ΔL were recorded
Whitening benefit was represented by negative b* (yellowness reduction), and positive ΔL (increasing lightness)
Notes Sample size calculation: done
Adverse effects: sensitivity
Health‐related quality of life: not reported
Key conclusions of the study authors: "Both groups experienced noticeable and significant ΔL*a*b* improvement at the end of the trial in comparison to the baseline. Significant improvement was observed in the first month for the tray group and in the first 2 months for the strip group (P < 0.05). While greater lightness improvement was observed in the tray group over the strip group in the first month, the opposite was noticed in the second month. There was no difference between 2 groups at the end of this trial and no adverse reactions were observed"
Correspondence required: no
Contact: Dr Botelho MG; botelho@hku.hk
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were randomly assigned to either group….. tossing coin"
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Participants were clinically review by one reviewer who was blinded to their treatment." However, method of blinding is not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Participants were clinically review by one reviewer who was blinded to their treatment." However, method of blinding is not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "..each group had 1 participant that did not attend 2 months review"
Comment: missing outcome data balanced in numbers across intervention groups
Selective reporting (reporting bias) Low risk All outcomes described were reported. Conclusions are in accordance with the results
Other bias Low risk None