| PubMed ID | Author / Year | Patient Group | Study type (level of evidence) |
| 23067089 | Sonthalia/2012 | n = 40 | RCT |
| Key results | 40 patients were enrolled with histologically proven diagnosis of OLP. The patients were randomly divided into 2 groups: twenty patients were assigned the use of clobetasol propionate (0.05%) ointment (topical corticosteroid) twenty patients were assigned the use of tacrolimus (0.1%) ointment (topical immunosuppressant), for eight weeks each. The patients were instructed to apply the ointment twice a day during the treatment period. Both groups were additionally instructed to use chlorhexidine mouthwash three times per day during the 8 week period. All patients were assessed at 2 weeks, 4 weeks and 8 weeks and at one post treatment visit at 12 weeks. Treatment was assessed based on the area involved and the severity of OLP lesions. 70% of patients in the clobetasol group achieved complete or partial response at 8 weeks, as compared to 95% in the tacrolimus group (p=0.091). There was improvement in patient reported symptoms, although the difference between the groups was not statistically significant (p > 0.05). The study concluded that topical application of 0.05% clobetasol and 0.1% tacrolimus were both effective in treating OLP. Limitations of this study include its small sample size and short duration. | ||
| 18230389 | Radfar/2008 | n = 30 | RCT |
| Key results | This study recruited 30 patients with lesions that were rendered a clinical and histological diagnosis of oral lichen planus. Patients were randomly assigned to 2 treatment groups; fifteen patients received treatment with clobetasol 0.05% ointment and fifteen patients received treatment with tacrolimus 0.1% ointment, each for 6 weeks. Both groups were instructed to apply the ointment 4 times/day for 2 weeks followed by 3 times/day for 2 weeks, 2 times/day for 1 week, and 1 time/day for 1 week. All patients were asked to rinse with nystatin 1 time/day during the treatment period in order to prevent oral candidiasis. All patients had 3 visits, which consisted of measuring the lesion, and a pain assessment evaluation using a visual analog scale (VAS). After 6 weeks of treatment, the mean reduction in lesion size was 82.6% in the tacrolimus group, and 81.6% in the clobetasol group. VAS scores after 6 weeks of treatment suggested improvement (p< .0001), however there was no statistical difference in improvement in symptoms between the two groups. The study concluded that topical application of tacrolimus is as effective as clobetasol in the treatment of OLP. | ||
| 18269664 | Corrocher /2008 | n= 32 | RCT |
| Key results | This study recruited 32 patients with histologically confirmed OLP. Patients were randomly assigned to two treatment groups; sixteen patients received 2ml of tacrolimus 0.1% ointment, and sixteen patients received 2ml of clobetasol propionate 0.05% ointment. Both groups were instructed to apply the topical medication four times daily for 4 weeks. Patients were evaluated at 3 points: a) baseline assessment, b) 4 weeks after initiating treatment, c) 6 weeks after initiating treatment. Mucosal lesional extension and symptoms of pain and burning were assessed during the three visits using a four-point scale. Prior to initiating treatment, there was no statistically significant difference in scores corresponding to pain, burning and mucosal extension between the two groups. At the end of 4 weeks of treatment and follow-up at 6 weeks, the median scores for pain, or burning sensation, and mucosal extension were significantly lower in the tacrolimus group as compared to the clobetasol group (p < 0.001). The study concluded that topical tacrolimus 0.1% ointment was significantly more effective in treating OLP as compared to topical clobetasol propionate 0.05% treatment. | ||
The Evidence
| Basic Science Rationale (Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?) |
| None available |
| Comments and Evidence-Based Updates on the CAT (FOR PRACTICING DENTISTS', FACULTY, RESIDENTS and/or STUDENTS COMMENTS ON PUBLISHED CATs) |
| None available |