Investigating the effectiveness of melatonin-containing mucoadhesive on minor recurrent aphthous stomatitis

Determination of the effectiveness of melatonin-containing mucoadhesive on minor recurrent aphthous stomatitis

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 44 patients. Random allocation software 2 for randomization.

Toouba Dental Clinic, Mazandaran University of Medical Sciences How to intervene in the intervention group (with melatonin mucosal adhesive) and control (placebo): Mucosal adhesive 3 times a day (Morning, afternoon and night) for 30 minutes and removing then (In addition to the examination on the day of visit), the patient should revisit on the third, fifth, and seventh days to have the pain level with the Visual analogue scale, the size of the ulcer with the probe, as well as the length of the healing period In this double-blind study (researcher, analyst and participant) for blinding, codes A (melatonin) and B (placebo) will be generated using software. Finally, the codes will be placed in a sealed envelope and the sample number will be written on the envelope. These envelopes, along with the mucosal adhesive, will be in dark packaging with the same color and shape.

Inclusion: Men and women aged 18 to 50 years, with aphthous lesions (up to 48 hours from the formation of the lesion, with a size less than 10 mm and a diameter greater than 2 mm), lesions of the lips and buccal mucosa Exclusion: pregnancy or lactation, ulcers as a manifestation of a systemic disease, use of non-steroidal anti-inflammatories, opioids, immunomodulatory agents, and analgesics

3 pieces of mucosal adhesive will be glued daily (a total of 21), use for 30 minutes (without eating or drinking at the time of use) and removing then by patient

pain; size of the lesion

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.

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.