Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for OLP. We report on the efficacy and safety of a novel mucoadhesive clobetasol patch (Rivelin® -CLO) for the treatment of OLP. METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life. RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-µg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%). CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.

Autotransplantation of teeth to the anterior maxilla: A systematic review of survival and success, aesthetic presentation and patient-reported outcome.

BACKGROUND/AIM: Autotransplantation of teeth to the anterior maxilla may be indicated after trauma or in patients with congenitally missing teeth. The aim of this systematic review was to report the current evidence concerning survival and success rate, aesthetic outcome, and patient-reported outcome of autotransplanted teeth to the anterior maxilla. MATERIALS AND METHODS: A MEDLINE search followed by an additional hand search was performed to identify relevant literature. All levels of evidence except case reports were considered. Any publication reporting on 10 or more autotransplanted teeth to the anterior maxilla, and written in English were eligible for this systematic review. RESULTS: The systematic search identified 95 abstracts. Thirty-seven full-text articles were evaluated of which 17 could finally be included. Data on survival and success rate of the transplants could be extracted from 11 studies. Survival rates ranged between 93% and 100% (weighted mean: 96.7%, median: 100%) after 9 months to 22 years of observation (median: 8.75 years). No consensus regarding definition of success criteria of the transplants could be found in the literature. Two and four studies contained data on aesthetic and patient-reported outcomes, respectively. In general, they reported favourable aesthetic results and high patient satisfaction. CONCLUSION: The current available evidence suggests a high survival rate after autotransplantation of teeth to the anterior maxilla. However, the level of evidence is low. Limited data on aesthetic and patient-reported outcomes warrant additional research in this field.