Fu 2012.
Methods | Study design: RCT Conducted in West China Number of centres: 1 (Department of Oral Medicine, School of Stomatology, Sichuan University) Recruitment period: September 2009 to December 2009 Funding source: unspecified |
|
Participants | Inclusion criteria: histopathologically and clinically diagnosed with erosive OLP; presence of a single erosion lesion; aged from 18 to approximately 70 years; erosive area not exceeding 1.5 cm²; and normal physical examination results before medication (including complete blood cell count, renal and hepatic clinical chemistry examination, urine and stool routine test, blood pressure examination, ultrasonic examination of abdomen, chest x‐ray and electrocardiogram). Exclusion criteria: presence of severe systemic diseases or other severe oral mucous diseases; use of antibiotics within 1 month or immunomodulating drugs within 3 months; history of topical treatment within 1 week; presence of lichenoid reaction caused by amalgam fillings or certain drugs (including beta‐blockers, dapsone, oral hypoglycaemics, non‐steroidal anti‐inflammatory drugs, penicillamine, phenothiazines, sulphonylureas and gold salts); pregnancy, intention of pregnancy, breastfeeding or recent use of steroid hormone‐based contraceptives; history of psychiatric disorders; participation in any other clinical trials in the 3 months before enrolment in study; refusing to follow medical advice; or could not finish the return visits Group A: randomised 20; analysed 19 Group B: randomised 18; analysed 17 |
|
Interventions | Group A: amlexanox paste 250 mg, 3 times daily for 1 week Group B: dexamethasone paste 6.45 mg (0.043%), 3 times daily for 1 week |
|
Outcomes | Pain (VAS), size of erosive area, adverse effects | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were assigned to the experimental group or positive‐control group by using a computer generated random number list." |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: the trial authors reported that the containers were the same, but no details were reported about blinding of personnel or the assessor, so we judged the study as unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: the trial authors reported that the containers were the same, but no details were reported about blinding of personnel or assessor, so we judged the study as unclear. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing data balanced in numbers across intervention groups (1 and 1) and not likely to have a clinically relevant impact on the intervention effect estimate. Unlikely to have introduced bias. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |