Bakhtiari 2017.
Methods | Study design: RCT Conducted in Iran Number of centres: 1 Recruitment period: unclear Funding source: unspecified |
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Participants | Inclusion criteria: clinically and histopathologically diagnosed with reticular and erosive LP, seeking medical management Exclusion criteria: presence of histological signs of dysplasia, use of drugs which caused lichenoid reactions, therapy for OLP in 2 months prior to the study, pregnant or breastfeeding women, uncontrolled systemic disease, lesions adjacent to amalgam fillings and people with photosensitivity Group A: randomised 15; analysed 15 Group B: randomised 15; analysed 15 |
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Interventions | Group A: dexamethasone mouthwash (0.5 mg in 5 mL of water) 4 times daily + 1 nystatin mouthwash 4 times daily for 2 weeks Group B: methylene blue as photosensitiser and light source of LED 630 nm (Fotosan, Denmark). Device was used according to manufacturer's instructions. Output power was 7.2–14.4 J/cm² and probe diameter was 8 mm. Participants gargled methylene blue 5% for 5 minutes and 10 minutes prior to irradiation. Each lesion was irradiated for 30 seconds up to 2 minutes with spot technique |
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Outcomes | Pain (VAS), clinical score (Thongprasom), clinical severity index, EI Measured at days 15, 30, 60 and 90 after beginning of the treatment |
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Notes | VAS results were reported graphically; data extraction was not possible | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: blinding not feasible. |
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 analysis. |
Selective reporting (reporting bias) | High risk | Comment: ≥ 1 outcomes of interest were reported incompletely (standard deviations were missing) so data could not be entered in a meta‐analysis. |
Other bias | Low risk | No other sources of bias identified. |