Dillenburg 2014.
| Methods | Study design: RCT Conducted in Brazil Number of centres: 1 Recruitment period: February 2012 to November 2012 Funding source: supported by Postgraduate Research Group of Porto Alegre University Hospital |
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| Participants | Inclusion criteria: aged > 21 years, symptomatic atrophic/erosive OLP, histopathological diagnosis of OLP based on WHO‐based criteria Exclusion criteria: pregnancy or nursing women, histological signs of dysplasia, OLP therapy in the previous 3 months, amalgam restorations near the lesions and the use of medications associated with oral lichenoid reactions Group A: randomised 21; analysed 16 Group B: randomised 21; analysed 17 |
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| Interventions | Group A: clobetasol propionate gel 0.05% 3 times daily for 4 weeks and nystatin 100,000 UI/mL oral rinses 3 times daily Group B: InGaAIP laser applications, 3 times weekly for 4 weeks (12 sessions) and nystatin 100,000 UI/mL oral rinses 3 times daily |
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| Outcomes | Pain (VAS), clinical score (Thongrasom), functional score (Lilleby score – 5 grades), relapse rate, anxiety questionnaire (Beck Anxiety Inventory), adverse effects Measured once weekly during treatment (days 7, 14, 21 and 30) and 4 weeks (day 60) and 8 weeks (day 90) after treatment |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The patients were randomly assigned to one of the two treatment groups using computer‐generated random number tables." |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The patient was not blinded to the treatment." |
| 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 | High risk | 5/21 (23.8%) participants from Group A and 4/21 (19%) from Group B were lost at follow‐up. |
| Selective reporting (reporting bias) | High risk | Comment: data on Beck Anxiety Inventory and Lillebay score not reported or impossible to extract. |
| Other bias | Low risk | No other sources of bias identified. |