Laeijendecker 2006.
Methods | Study design: RCT Conducted in Netherlands Number of centres: 1 Recruitment period: 2001–2004 Funding source: unspecified |
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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 |
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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 |
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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. |