Ezzatt 2019.
| Methods | Study design: RCT Conducted in Egypt Number of centres: 2 (Department of Oral Medicine, Oral Diagnosis and Periodontology, Faculty of Dentistry and the Department of Skin and Venereal Diseases, Faculty of Medicine in Ain Shams University‐Egypt) Recruitment period: unspecified Funding source: supported by the principal investigator's own funds |
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| Participants | Inclusion criteria: systemically free, both genders aged 25–60 years, clinically and histologically confirmed painful erosive or atrophic OLP according to modified WHO criteria Exclusion criteria: history of drug‐induced lichenoid lesions, potential treatment of OLP for < 2 weeks by topical and 4 weeks systemic therapy before study, pregnancy, breastfeeding, smoking and known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation Group A: randomised 15; analysed 15 Group B: randomised 15; analysed 15 |
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| Interventions | Group A: betamethasone 17‐valerate 0.1% adhesive gel base, 4 times daily for 4 weeks Group B: pimecrolimus adhesive 1% gel base, 4 times daily for 4 weeks |
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| Outcomes | Pain (VAS), clinical score (5‐grade scale), adverse effects | |
| Notes | All the outcomes were reported in a way that allowed us to perform quantitative analysis. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomization assignment (blocks of 4)." |
| Allocation concealment (selection bias) | Low risk | Quote: "Allocation concealment was performed by sealed envelopes containing the randomization number." |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "both patients and outcome assessors were blinded for the type of medication." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "both patients and outcome assessors were blinded for the type of medication." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data. All randomised participants included in the result analysis. |
| Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
| Other bias | Low risk | No other sources of bias identified. |