Siponen 2017.
| Methods | Study design: 3‐arm parallel RCT Conducted in Finland Number of centres: 2 (Oulu and Kuopio) Recruitment period: June 2014 to December 2014 Funding source: Finnish Dental Society Apollonia, EVO Funds Oulu University Hospital, EVO/VTR Funds Kuopio University Hospital, Sigrid Juselius Foundation, and MRC Oulu University Hospital |
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| Participants | Inclusion criteria: diagnosis of symptomatic OLP, clinical score ≥ 20 (including VAS > 0), aged > 18 years, washout period of 2 weeks Exclusion criteria: pregnancy or current nursing; allergy to TAC, other macrolides or other substances used in the study medications; hepatic insufficiency; and use of medications that could have significant interactions with TAC, including ciclosporin, erythromycin, rifamycin, posaconazole, itraconazole, ketoconazole, fluconazole, voriconazole, rifampicin, phenytoin and dabigatran Group A: randomised 11; analysed 11 Group B: randomised 7; analysed 7 Group C: randomised 9; analysed 9 |
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| Interventions | Group A: tacrolimus ointment 0.1% 3 times daily for 3 weeks Group B: triamcinolone acetonide ointment 0.1% 3 times daily for 3 weeks Group C: placebo (Orabase) 3 times daily for 3 weeks |
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| Outcomes | Changes in clinical scores (modified from Setterfield) from baseline to week 3, changes in VAS scores from baseline to week 3, adverse events | |
| Notes | Since clinical score and pain were reported only as percentage of change from baseline, they were not included in the quantitative analysis. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Computer‐generated randomisation lists." |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was ensured by keeping the randomisation lists in the care of one of the investigators (TS) who was not involved in the clinical part of the study." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double blind." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis. 4/27 (15%) participants lost at follow‐up, balanced across groups (2, 1 and 1). |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
| Other bias | Low risk | No other sources of bias identified. |