Recurrent Aphtous Stomatitis. Recurrent oral aphthae
Conditions
Interventions
Intervention 1: Intervention group: omega-3 soft gelatin capsules(Zahravi Company, Tehran, Iran) of 1000 mg 3 times daily , 6 months. Intervention 2: Control group: placebo soft gelatin capsules 3 tim
Treatment - Drugs
Placebo
Intervention group: omega-3 soft gelatin capsules(Zahravi Company, Tehran, Iran) of 1000 mg 3 times daily , 6 months
Control group: placebo soft gelatin capsules 3 times daily for 6 months
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: both male and female with older than18 years of age having recurrent minor aphthous ulcer for at least 1 year with a frequency of at least 1 outbreak per month presenting with 1 to 3 aphthous ulcers (of less than 48 hours’ duration) with a size no greater than10 mm in diameter withoutanesthesia or paresthesia
Exclusion criteria
Exclusion criteria: individuals who had concurrent clinical conditions that could pose a health risk to the participants,including serious heart, liver, or kidneydys functions pregnancy or lactation ulcers as a manifestationof systemic disorders such as ulcerative colitis, Crohn disease, Behçet syndrome, or serious anemia use of medications such as systemic steroids,immunomodulatory agents, antibiotics, or nonsteroidalanti-inflammatory drugs within 1 month before study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of aphtous ulcer. Timepoint: First appointment; monthly for 6 months. Method of measurement: Count the ulcers.;Level of pain. Timepoint: First appointment, monthly for 6 months. Method of measurement: Visual Analogue Scale (VAS ).;Average duration of ulcer episodes. Timepoint: First appointment; monthly for 6 months. Method of measurement: Number of days.;The average score of COMDQ. Timepoint: First appointment; 6 month later. Method of measurement: Filling the questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAtena Shirzad
Babol University of Medical Sciences
Outcome results
None listed