Effect of ANSIL to improve recurrent aphthous stomatitis: A double-blind clinical trial

Abstract

Recurrent aphthous stomatitis is the most common type of inflammation of the oral mucosa with an average prevalence of 25.2% in Iran. A mature and developed ulcer has a yellow necrotic center and a smooth and transparent border surrounded by erythematous halos. Mainly the buccal mucosa and lips are infected. Keratinized mucosa of the palate and gums are less involved. Etiologically, aphthous stomatitis is a multifactorial lesion. However, the main cause is still unknown. Trauma factors, infection, hormonal factors, genetic talent, blood factors such as iron deficiency anemia, neutropenia, immune system abnormalities, stress and allergies are considered as predisposing factors. The most common local wound treatment methods include the use of local drugs such as antibiotics, analgesics, and immunosuppressive agents. Corticosteroids are routinely prescribed to treat these lesions, but their use is being phased out due to several side effects. In this plan, the aim is to introduce and evaluate clinically a solution called ANSIL for the healing of mouth sores, which is a combination of zinc oxide nanoparticles, silver, and plants such as milk thistle, chamomile, almond oil, and glycerin. Methods: 80 patients with oral thrush were included in this clinical trial. The patients included in the study were randomly divided into four groups using the online graphpad software. In other words, four groups of 20 patients were formed. 3 groups of patients received 100ppm, 50ppm and 150ppm doses of Ansil solution. The fourth group received the solution base formulation without medical substances (deionized water). The duration of using the solutions will be for 7 days. Then, the duration of complete recovery of the pest was compared between the groups. Also, the intensity of pain on days 0, 3 and 7 in the studied groups was checked using the VAS questionnaire Results: Compared to placebo, 150 ppm solution was not statistically significant on the severity of mouth sore pain on days 3 and 7 (p<0.05). The 100ppm solution was statistically significant compared to the placebo both on day 3 and day 7, and it reduced the severity of mouth sore pain (p<0.05). 50 ppm solution compared to placebo was statistically significant only on day 7 (p<0.05) and has reduced pain. The 100 ppm solution was significant in terms of recovery time on day 7 compared to placebo and reduced the recovery time (p=0.0).