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IRCT20240712062408N1 IRCT 2024-12-06 Mazandaran University of Medical Sciences The effect of melatonin on aphthous ulcers Investigating the effectiveness of melatonin-containing mucoadhesive on minor recurrent aphthous stomatitis 2024-12-10 anticipated 44 Complete https://irct.ir/trial/80327 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to allocate the samples to two groups, the random block method will be used. For this purpose, patients will receive numbers 1 to 44. The randomization unit will be individually and according to the number with blocks of 2 people. The selection of the type of group for each person will be done through random allocation 2 statistical software. Using the software, codes A and B will be generated. Finally, the codes will be placed in a sealed envelope and the sample number will be written on the envelope. After the arrival of each sample, the doctor will test the desired drug, which is placed in dark packages with the same color and shape and is supplied with each envelope on the patient, Blinding description: Double-blind (i.e., the patient, the data collector (researcher, clinical caregiver and outcome assessor), and the person conducting the statistical analysis are unaware of and blind to the intervention). These people will not know how to distribute the adhesives, and the adhesives will be available to patients in dark packages with the same color and shape. 3 minor recurrent aphthous stomatitis. 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information available
public Pouria Jahanbani
Khazar Blvd., Touba dental clinic
Sari Iran (Islamic Republic of) 4816895475 +98 11 3340 5474 p.jkenari@gmail.com Mazandaran University of Medical Sciences scientific Pouria Jahanbani
Khazar Blvd., Touba dental clinic
Sari Iran (Islamic Republic of) 4816895475 +98 11 3340 5474 p.jkenari@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 50 years Both 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 K12.0 Recurrent oral aphthae Treatment - Drugs Placebo 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). Control group: plasebo; The chemical composition and method of use will be similar to the main medication but without melatonin. 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. Mazandaran University of Medical Sciences Approved 2024-10-01 Ethics committee of Mazandaran University of Medical Sciences Moallem Square, Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)