minor recurrent aphthous stomatitis. Recurrent oral aphthae
Conditions
Interventions
Intervention 1: Intervention group: Use of mucosal adhesive containing melatonin
Chemical composition: Avicel® (20mg), Magnesium stearate (2.5mg), Corn starch (7mg), D-mannitol (40mg), Aerosil® 200 (0.5mg), Carbopol 974p (5mg), Polyethylene glycol 6000 (10mg), Melatonin (15mg)
Dose: 45 mg of melatonin per day, one 15 mg muco-adhesive each time (3 times)
Duration of use: until the lesion heals (maximum 7 days). Intervention 2: Control group: plasebo
The chemical composition and method of use will be similar to the main medication but without melatonin.
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Men and women aged 18 to 50 years who have the ability to follow the doctor's recommendations who are willing to participate in the study and do not use painkillers during it who have a Aphthous ulcer (no more than 48 hours have passed since the lesion formed;) with a size smaller than 10 mm and a diameter greater than 2 mm patients who have Aphthous ulcer in the lips and buccal mucosa (due to greater availability and fewer movements, which allow the mucusal adhesive to remain on the lesion)
Exclusion criteria
Exclusion criteria: Due to insufficient information on drug interactions of melatonin, individuals using other medications should also be excluded from the study Pregnancy or lactation Ulcer as a manifestation of a systemic disease such as Behçet's disease, ulcerative colitis, Crohn's disease, or acquired immunodeficiency Use of nonsteroidal anti-inflammatory drugs, narcotics, immunomodulating agents, systemic antibiotics within 2 weeks prior to study entry Treatment with any oral topical medication within 1 month prior to study entry Invasive dental procedure within 2 weeks prior to study entry Patient using toothpaste containing anti-inflammatory drugs Individuals working night shifts should also be excluded due to the possible drowsiness effects of melatonin Use of sedatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The distance between the 2 outer edges of the ulcer border in mm; lesions less than 1 mm in diameter will be considered healed. Timepoint: The day of referral (starting the use of the drug), the third, fifth and seventh day after that. Method of measurement: To determine the wound size, the researcher measures the distance between the 2 outer edges of the wound border in millimeters using a calibrated dental probe (D&G, Pakistan).;Patients are taught to determine the intensity of their pain based on a visual analogue scale. Patients will record their pain in a checklist 3 times a day after each meal and lesions with a pain value of 1 cm or less will be considered healed. Timepoint: 3 times a day until the lesion heals. Method of measurement: Using a visual analogue scale, so that the patient marks his pain level from 0 to 10 3 times a day after each meal on a 10 cm line. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactPouria Jahanbani
Mazandaran University of Medical Sciences
Outcome results
None listed