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. 2020 Feb 28;2020(2):CD001168. doi: 10.1002/14651858.CD001168.pub3

Laeijendecker 2006.

Methods Study design: RCT
Conducted in Netherlands
Number of centres: 1
Recruitment period: 2001–2004
Funding source: unspecified
Participants Inclusion criteria: Caucasian people with a confirmed diagnosis of symptomatic OLP based on clinical and histopathological features
Exclusion criteria: aged < 18 years; histopathological examination with atypical or lichenoid dysplastic features; asymptomatic oral lesions and specific treatment within 4 weeks prior to the study
Group A: randomised 20; analysed 20
Group B: randomised 20; analysed 20
Interventions Group A: tacrolimus 0.1% ointment, 4 times daily for 6 weeks
Group B: triamcinolone acetonide 0.1% in hypromellose 20% ointment, 4 times daily for 6 weeks
Outcomes Clinical score (4‐grade score), adverse effects
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "pre‐determined randomisation list stratified by sex."
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient information to permit judgement.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to permit judgement.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no missing data. All randomised participants included in analysis.
Selective reporting (reporting bias) Low risk Planned outcomes reported.
Other bias Low risk No other sources of bias identified.