EFFECTIVENESS OF A POLYMER-BASED MUCO-ADHESIVE IN THE HEALING OF AUTOIMMUNE/ULCERATIVE CONDITIONS PILOT STUDY

Objective. The Aims of this study are: 1- To verify the effectiveness of MuGardTM as a mucoadhesive, capable to heal the oral autoimmune ulcers. 2- To verify the effectiveness of MuGard to decrease erythema. 3- To verify the effectiveness of MuGard to decrease pain 4- To verify the effectiveness of MuGard to decrease infection Background. Inflammation and ulceration of the oral mucosa occur in a number of different conditions. Oral 28 mucositis (OM) can be both painful and dangerous. The pain is often present both at rest and upon swallowing, or even talking. Painful swallowing can cause patients to stop eating and drinking, leading to both malnutrition and dehydration. Open wounds (ulcerations) can allow the ingress of micro-organisms, leading to infection. Quality of life for these patients is poor1. OM frequently occurs soon after the initiation of chemo- or radiation-therapy for the treatment of head and neck cancers. Previous studies have shown that an oral rinse, Mugard , started at the beginning of such treatments, greatly reduces the incidence and severity of OM signs and symptoms2,3. The unique aspect of the present study will be to begin evaluating the ability of Mugard to reduce the signs and symptoms of OM in patients who have already developed the condition due to having an autoimmune disease, such as Sjögren syndrome, systemic lupus erythematosus, pemphigus vulgaris, mucus membrane pemphigoid, epidermolysis bullosa acquisita, and erosive lichen planus. Methods. This pilot study is to gather data that will enable us to perform a sample size analysis for a future full-blown randomized control, double blind, trial (RTC). The patients recruited from the Dental Clinics at NSU, with documented diagnosis of immune mediated ulcerative or blistering conditions, who are not receiving systemic steroids, participate in the study. Exclusion criteria: Patients using other oral rinses to coat the mucosa, patients taking systemic steroids, infants and pregnant patients, because there have been not studies regarding these users. Two outcome measures were employed. The first was the Oral Mucositis Assessment Scale (OMAS), introduced by Sonis, et al, 1999; and validated as reliable. The second outcome measure was a visual analogue scale (VAS) in which patients rate subjectively the pain they are experiencing. Since pain due to mucositis is experienced both at rest as well as on speaking and swallowing, patients rated their pains separately for all three conditions (Appendix B). Each of these measures was obtained: 1) At initial intake, that is, prior to being randomized into either of the two groups (experimental or placebo) and therefore before treatments begin. 2) These measures were repeated three times, namely on days 2, 7, and 14 following the initiation of treatment. Blinding After each patient\u27s initial evaluation, he/she was randomly assigned to either treatment group by a research assistant who is not otherwise involved with patient treatment or evaluation. This assistant assigned each patient a unique ID number which only the assistant knew. Based on this ID number, the assistant supplied the patient with the appropriate “medication”, which is either the Mugard itself, or the placebo Mugard. Thus, the patient did not know his/her treatment, and the investigator performing all subsequent evaluations did not know the patient\u27s treatment category.After all data have been collected, but still without knowing treatment assignments, Drs. So-and-so and soand- so will compile, for each patient, his/her initial OMAS scores and VAS ratings, and also their three subsequent follow-up studies. Only after all such individual evaluations and scores were determined, the code was broken so that the subjects were placed into their assigned treatment categories. Next, the initial OMAS and VAS scores of the two groups was compared using the nonparametric Mann-Whitney test to determine if the two groups were statistically similar before actual treatments began. Each group was first be compared to its own baseline values using the Friedman\u27s test, which is a non-parametric equivalent of the repeated measures ANOVA. This gave light on whether either group improved statistically compared to its own baseline (a within-group measure). Then, the final values (i.e., those after 14 days of treatment) were compared statistically, again using the Mann-Whitney test, to determine if a significant difference was present. Results. The preliminary results are promising.The initial analysis shows that there is a statistically significant difference between the placebo and the MuGard group Conclusion. At this point, this research suggests that MuGard is effective in the healing of autoimmune ulcerative conditions. Grants. HP