Efficacy of oral supplement omega-3 in treatment of recurrent aphthous stomatitis and improvement of oral health related quality of life

Eevaluation the efficacy of oral supplement omega-3 in treatment of recurrent aphthous stomatitis and improvement of oral health related quality of life

In this double-blind clinical trial, 40 patients with recurrent aphthous stomatitis who referred to the Oral Medicine Department of the Faculty of Dentistry of Babol University of Medical Sciences were selected. After matching with the inclusion and exclusion criteria, these individuals are randomly ( flip the coin) assigned to two groups of 20 control and intervention groups. The placebo group receives placebo capsules and the intervention group receives omega-3 capsules (DeraPakhsh, Iran).

The participants were selected from patients referred to the clinic of oral medicine department of the faculty of dentistry of Babol university of medical sciences. Participants who met the inclusion/exclusion criteria received verbal information about the study. Intervention group received omega-3 capsules of 1000 mg each (Zahravi Company, Tehran, Iran) tree times a day for six month and control group received placebo capsules with the same prescription. At baseline appointment and monthly follow-up visits (for 6 months), a questionnaire for the average number of ulcers, the amount of pain (VAS), and the amount of time of the wound present are filled for each patient. patients filled persian version of the chronic oral mucosal disease questionnaie (COMDQ) were ranked by the patients To evaluate treatment effectiveness two times: at the baseline appointment and 6 months later.

Inclusion criteria in case and control groups: both male and female with older than18 years of age; having recurrent minor aphthous ulcer for at least 1 year ; presenting with 1 to 3 aphthous ulcers (of less than 48 hours’ duration) exclusion criteria in case and control groups: individuals heart, liver, or kidneys disease; pregnancy or lactation; ulcers as a manifestation of systemic disorders such as ulcerative colitis, Crohn disease, Behçet syndrome ; use of medications such as systemic steroids,immunomodulatory agents, or nonsteroidal anti-inflammatory drugs within 1 month before study entry.

experimental group (omega-3 group) included patients with recurrent aphtous stomatitis who received omega-3 soft gelatin capsules(Zahravi Company, Tehran, Iran) of 1000 mg 3 times daily control group (placebo group) included patients with recurrent aphthous stomatitis who received placebo soft gelatin capsules 3 times daily

number of new ulcer outbreaksک the average level of pain using a visual analog scale (VAS); the average duration of ulcer episodes; the average score of COMDQ

In this study, individuals were randomly divided into two groups of omega-3 capsules and placebo capsules using coin throwing.

In order to eliminate the error from the knowledge of the patient or assessor's dentist to the type of treatment received and its possible impact on the outcome of the study, a double-blind study is done. Given that the omega-3 capsules and placebo are placed in the same full capsule, the patient and the assessing dentist are not aware of the type of medication received.