Zinc Sulphate 5%Mouthwash is an Effective Therapeutic and Prophylactic Agent in Treatment of Recurrent Aphthous Ulcer (Single blind placebo controlled therapeutic study)

Abstract

Background: Recurrent aphthous ulcer (RAU) is a common disease where its exact etiology and pathogenesis are not known. There is no uniformly effective therapy for this disease. Recent study showed that oral zinc sulphate has effective therapeutic and prophylactic role in management of this disease.Objective: To evaluate the therapeutic, prophylactic efficacy and safety of 5% zinc sulphate mouthwash in the management of patients with RAU.Patients and Methods: This is single blind placebo controlled therapeutic study where 40 patients with early onset oral aphthosis were recruited in this work those who attended Baghdad Teaching Hospital-Department of Dermatology between April 2005- April 2006. Patients were divided into two groups: Group A (20 patients) were instructed to use 5% zinc sulphate mouthwash, 5 ml twice daily for three months, while 20 patients in Group B used placebo in a form of distilled water mouthwash and in a similar way to zinc sulphate mouthwash. A short term assessment of each patient of both groups was done to evaluate the therapeutic effect of the drug by using oral clinical manifestation index (OCMI and the mean size of the largest diameter of ulcers. A long term assessment was done for each patient to evaluate the prophylactic effect of the drug by using (OCMI) before, after 1, 2 and 3 months of therapy. Results: The patient included in this study 19 males (47.5%) and 21 females (52.5%), female to male ratio was 1.1: 1. Their ages ranged between 20-60 (29.6 ± 9.6 ) years. The mean of OCMI in Group A started to decline directly after 4 days of therapy and went to its lower level after 8 days of therapy, and it was statistically significant (P value <0.05). The change in the mean of OCMI of Group B after 4 and 8 days of therapy was also statistically significant (P value <0.05). The response rate (percentage of change in the mean) after 4 days of therapy in Group A was 22.65% and in Group B was 6.44%, while the response rate after 8 days of therapy in Group A was 66.33% and in Group B was 44.98%. The difference in the response rates after 4 and 8 days between Group A and B was statistically significant (P value <0.05). The mean size of ulcers in Group A started to decline directly after 4 days of therapy and to its lower level after 8 days of therapy, and it was statistically significant (P value <0.05). The change in the mean size of ulcers of Group B after 4 and 8 days of therapy was also statistically significant (P value <0.05). The response rate after 4 days of therapy in Group A was 44.30% and in Group B was 15.08%, while the response rate after 8 days of therapy in Group A was 83.54% and in Group B was 55.36%. The difference in the response rates after 4 and 8 days between Group A and B was statistically significant (P-value <0.05). So the therapeutic effect of zinc sulphate mouth wash was statistically more significant than placebo effect. No significant side effects were noticed apart from mild irritation in two patients using zinc sulphate. Zinc sulphate mouth wash showed statistically significant prophylactic effect in comparison to placebo after 1, 2 & 3 months from starting therapy using the oral clinical manifestation index. Conclusions: Zinc sulphate 5% mouthwash is a new, safe effective therapeutic and prophylactic remedy in management of RAU. The mechanism of action could be related to its immunomodulatory, antimicrobial, antioxidant actions and effects on wound healing