Conrotto 2006.
Methods | Study design: RCT Conducted in Italy Number of centres: 1 Recruitment period: 1999–2002 Funding source: company provided drugs |
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Participants | Inclusion criteria: clinical and histological OLP; painful lesions Exclusion criteria: presence of histological signs of dysplasia; use of lichenoid reaction‐inducing drugs; presence of amalgam fillings close to lesions; therapy for OLP in the 6 months prior to the study; skin, genital or other extraoral lesions; pregnant or breastfeeding women Group A: randomised 20; analysed 19 Group B: randomised 20; analysed 20 |
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Interventions | Group A: clobetasol propionate 0.025% in 4% hydroxyethyl cellulose gel, twice daily for 2 months Group B: ciclosporin 1.5% in 4% hydroxyethyl cellulose gel, twice daily for 2 months |
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Outcomes | Pain resolution, clinical score (Thongprasom), adverse effects, cost | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated random number tables." |
Allocation concealment (selection bias) | Low risk | Authors implied that the allocation list was hidden and allocation performed by pharmacy. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind"; however, ciclosporine has a distinct foul taste so assessed as 'unclear' |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double blind." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing data not likely to have a clinically relevant impact on the intervention effect estimate (1 participant from Group A). Unlikely to have introduced bias. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |