Hesen 2017.
Methods | Study design: 3‐arm RCT Conducted in Egypt Number of centres: 2 Recruitment period: unclear Funding source: unspecified |
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Participants | Inclusion criteria: both sexes, aged 25–60 years, with clinically and histologically confirmed erosive/atrophic OLP and free from any systemic disease Exclusion criteria: people with history of drug‐induced lichenoid lesions or potential treatment for OLP (for < 2 weeks by topical or 4 weeks by systemic therapy) before start of study; pregnant or breastfeeding women; smokers; known hypersensitivity or adverse effects to treatment drugs; losses of pliability or flexibility in tissues involved by oral lesions or histological signs of epithelial dysplasia or lichenoid lesions Group A: randomised 10; analysed 10 Group B: randomised 10; analysed 10 Group C: randomised 10; analysed 10 |
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Interventions | Group A: topical triamcinolone acetonide 0.1% oral paste (GEO ORALOG; Geopharma, Cairo, Egypt) 4 times daily + glucosamine sulphate 500 mg capsules orally 3 times daily (glucosamine; GlaxoSmithKline, Cairo, Egypt) for 8 weeks Group B: topical triamcinolone acetonide 0.1% oral paste twice daily + glucosamine sulphate 500 mg 3 times daily for 8 weeks Group C: topical triamcinolone acetonide 0.1% oral paste alone 4 times daily for 8 weeks |
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Outcomes | Pain (VAS, resolution), clinical score (Thongprasom Classification score) Measured at baseline, 1, 2, 4, 6, 8 and 12 weeks |
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Notes | We compared the outcomes of Group A and Group C as the triamcinolone daily dose was the same (4 times daily). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomised into three groups (10 patients each) using computer‐generated randomisation assignment." |
Allocation concealment (selection bias) | Low risk | Quote: "allocation concealment with sealed envelopes." |
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 | High risk | Comment: participants (self‐assessed, pain was primary outcome) were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing data. All randomised participants included in result analysis. |
Selective reporting (reporting bias) | High risk | Adverse effects, mentioned in the Methods were not reported in the Results. |
Other bias | Low risk | No other sources of bias identified. |