Amanat 2014.
Methods | Study design: split‐mouth RCT Conducted in Iran Number of centres: 1 Recruitment period: July 2012 to January 2013 Funding source: supported by Vice Chancellory of Shiraz University of Medical Sciences (no. 90010342) |
|
Participants | Inclusion criteria: bilateral clinically and biopsy confirmed OLP lesions (size > 4 cm), similar in form bilaterally with < 1 cm difference in size Exclusion criteria: systemic disease, pregnancy, drug consumption, smoking, people with lesions contacting dental amalgam, and people with dermal and other mucosal involvement at the time of the therapy. Participants did not receive any treatment for OLP at least 1 month prior to the beginning of the study. Randomised 30 participants; analysed 23 participants at final follow‐up (split‐mouth design) |
|
Interventions | Group A: triamcinolone acetonide ointment 0.1% in Orabase (3 times daily for 1 week, tapered to twice daily on week 2, once daily on week 3, alternate day on week 4 and discontinued at week 5) Group B: single session of cryotherapy with nitrous oxide gas |
|
Outcomes | Pain score (VAS), Thongprasom sign score (based on size and appearance), improvement scale based on EI (no improvement (EI = 0), mild improvement (EI > 0 to 25%), moderate improvement (EI ≥ 25% to < 75%), marked improvement (EI ≥ 75% to < 100%) and healed (EI = 100%) Measured before treatment and after 2, 4 and 6 weeks of treatment |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not feasible. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 7 (23%) lost to follow‐up. Quote: "Two patients chose to discontinue the study protocol after 3 weeks and other treatments were begun. Two patients were also excluded on week 4 due to poor compliance and wrong use of ointment. Three patients did not come for the third follow‐up session." |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | No other sources of bias identified. |