MuGard, an oral mucoadhesive hydrogel, reduces the signs and symptoms of oral mucositis in patients with lichen planus: a double-blind, randomized, placebo-controlled pilot study Inez Velez, DDS, MS, a Neil I. Spielholz, PT, PhD, b Michael A. Siegel, DDS, MS, c and Tulia Gonzalez, DDS d Nova Southeastern University, Fort Lauderdale, FL, USA Objective. To determine if MuGard, a mouthwash shown to reduce the severity of oral mucositis when started before initiating antineoplastic therapy for head and neck cancers, is effective when painful, oral lesions are present in patients with biopsy-proven erosive oral lichen planus. Study Design. This was a double-blind, randomized, placebo-controlled pilot study at a college of dental medicine. Twenty patients with oral lichen planus were randomly assigned to receive either MuGard (n ¼ 10) or saline-bicarbonate control (n ¼ 10). One teaspoonful of the assigned mouthwash was swished for 1 minute, 5 times a day, for 14 days. Outcome measures (Oral Mucositis Assessment Scale scores and visual analog scale pain scores) were obtained before the start of treatment and repeated on days 2, 7, and 14. Results. Significant reductions in all outcome measures occurred in the MuGard-treated group. Number-needed-to-treat (NNT) to achieve a >50% reduction in averaged pain from baseline was 1.25, and to obtain complete relief, the NNT was 2.5. Conclusions. MuGard significantly reduces pain and ulceration associated with oral mucositis in patients with lichen planus. (Oral Surg Oral Med Oral Pathol Oral Radiol 2014;118:657-664) Oral mucositis consists of inflammation and ulceration of the oral mucosa, associated with pain at rest, on swallowing, and on speaking. Pain can seriously affect a patient’s quality of life. 1 Although the term oral mucositis is most commonly associated with antineo- plastic therapy (both chemotherapy and radiotherapy), the term pertains to mucous membrane inflammation when used literally. Oral mucosal inflammation occurs in other conditions, such as lichen planus, systemic lupus erythematosus, pemphigus vulgaris, and Crohn disease. 2 It is in this context that we use the term oral mucositis in this report. MuGard (Access Pharmaceuticals, Dallas, TX, USA) is a ready-to-use mucoadhesive, hydrogel oral rinse, with marketing allowance by the US Food and Drug Administration as a medical device. This designation is based on MuGard’s ability to form a thin adhesive coating on oral mucosal membranes, presumably pro- tecting them from saliva and microorganisms. When started shortly before the institution of chemotherapy or radiotherapy for head and neck cancers (i.e., before the development of mucositis), MuGard lessened the severity of the developing mucositis and pain as compared to 2 published historical “controls,” (i.e., patients that did not receive MuGard treatment) 3 and in a recent multicenter prospective randomized controlled trial (RCT). 4 In the prospective multicenter study, 4 the treated and placebo-treated patients started using MuGard immediately before antineoplastic therapy was initiated and then continued rinsing 4 times a day until they had received a cumulative radiation dose of 50 Gy to 72 Gy. 4 Lichen planus is one of several autoimmune diseases that can be associated with oral mucosal inflammation, and when this occurs, it is termed erosive lichen pla- nus. 2 In light of the reported success of MuGard to slow the development and lessen the severity of the signs and symptoms of oral mucositis in patients receiving antineoplastic therapy, 3,4 we instituted this small, A poster concerning this study was presented at the April 2014 meeting of the American Academy of Oral Medicine in Orlando, FL, USA. This study was funded by a President’s Faculty Research and Development Grant from Nova Southeastern University. Samples of MuGard and the saline-bicarbonate placebo were supplied by Access Pharmaceuticals. No author had a financial arrangement with Access Pharmaceuticals. a Professor and Director, Oral and Maxillofacial Pathology, Nova Southeastern University, College of Dental Medicine. b Professor, Oral Diagnostic Sciences, Nova Southeastern University, College of Dental Medicine. c Professor and Chair, Oral Medicine and Diagnostic Sciences, Nova Southeastern University, College of Dental Medicine. d Assistant Professor, Restorative Dentistry, Nova Southeastern Uni- versity, College of Dental Medicine. Received for publication Apr 7, 2014; returned for revision Jul 1, 2014; accepted for publication Jul 13, 2014. Ó 2014 Elsevier Inc. All rights reserved. 2212-4403/$ - see front matter http://dx.doi.org/10.1016/j.oooo.2014.07.007 Statement of Clinical Relevance MuGard mouthwash safely and effectively reduces the signs and symptoms of oral mucositis in patients with oral lichen planus. However, studies are still needed to determine whether these benefits are lasting. 657 Vol. 118 No. 6 December 2014