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IRCT20220411054501N1 IRCT 2022-04-25 Zanjan University of Medical Sciences Comparison of the effectiveness of LASER with Aphtogel in the treatment of aphthous ulcers of the oral mucosa Comparison of the effectiveness of 810 nm Diode LASER with Aphtogel mucoadhesive in the treatment of minor aphthous ulcers of oral mucosa (changes in diameter and pain of aphthous ulcers) in patients with minor aphthous ulcers 2022-04-29 anticipated 50 Complete https://irct.ir/trial/62923 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients are given a general explanation about the intervention methods, but one method is not introduced as superior to the other method and no preference is given to one of the interventions, so patients are blind to the effect of the intervention. 3 Minor aphthous ulcer of the oral mucosa. Intervention 1: Intervention group: Patients in this group will be exposed to Diode LASER (elexion) with a wavelength of 810 nm and a power of 0.5 watts in continuous mode with a fiber diameter of 320 μm and a total energy received of 12.9 joules per square centimeter for 3 days, 3 times a day and each time for 20 seconds with an interval of 10 seconds in an area 1.5 cm in diameter around the lesion at a distance of 1 cm from the tip of the fiber from the surface of the pest sores on their wounds. Intervention 2: Intervention group: This treatment is performed using Aphthogel, which is a mucoadhesive with plant base containing Licorice plant extract. This drug is produced by Exir Danesh Asia Company. The mucoadhesive is packed in the form of 25 adhesives. Each of these adhesives is in the form of a thin layer (less than 1 mm thick) with dimensions of 1 cm2. This mucoadhesive is applied directly to the oral plague.Instructions for using the mucoadhesive (Aphthogel) are explained to the patient as follows : 1. Open the package first. 2. Remove one of the labels and carefully place it on the pest. 3. Moisturize it with saliva, the Aphthogel easily adheres to the pest. 4. The label stays on the pest for 25-30 minutes and then the rest is removed.(Swallowing the drug is not prohibited) 5. Repeat this operation 4 times a day. Use of mucoadhesive continues until complete recovery. Yes - There is a plan to make this available What will be shared: All data can be shared potentially except the data that leads to identifiable individuals. When: Access period starts 6 months after the results are published. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Any kind of statistical analysis is allowed on the delivered data. Where to obtain: Dr Robab Noormohammadi , dr.noormohammadi@zums.ac.ir How to obtain: The applicant can submit his request via the said email. The requested files will be sent to him as soon as possible. Comments:
public Robab Noormohammadi
Unit 7, Nasim Building, Deljoui St., East Zeinabieh St., Middle Saadi
Zanjan Iran (Islamic Republic of) 4514667092 +98 24 3336 5508 dr.noormohammadi@zums.ac.ir Zanjan University of Medical Sciences scientific Robab Noormohammadi
Unit 7, Nasim Building, Deljoui St., East Zeinabieh St., Middle Saadi
Zanjan Iran (Islamic Republic of) 4514667092 +98 24 3336 5508 dr.noormohammadi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients referred to the clinic of Zanjan Dental School who have minor aphthous ulcers of the oral mucosa. Patients should be 10 to 80 years old. Complete the informed consent form by the patient 10 years 80 years Both Being a smoker Having a systemic disease predisposing to aphthous ulcers Treatment - Other Treatment - Drugs Intervention group: Patients in this group will be exposed to Diode LASER (elexion) with a wavelength of 810 nm and a power of 0.5 watts in continuous mode with a fiber diameter of 320 μm and a total energy received of 12.9 joules per square centimeter for 3 days, 3 times a day and each time for 20 seconds with an interval of 10 seconds in an area 1.5 cm in diameter around the lesion at a distance of 1 cm from the tip of the fiber from the surface of the pest sores on their wounds. Intervention group: This treatment is performed using Aphthogel, which is a mucoadhesive with plant base containing Licorice plant extract. This drug is produced by Exir Danesh Asia Company. The mucoadhesive is packed in the form of 25 adhesives. Each of these adhesives is in the form of a thin layer (less than 1 mm thick) with dimensions of 1 cm2. This mucoadhesive is applied directly to the oral plague.Instructions for using the mucoadhesive (Aphthogel) are explained to the patient as follows : 1. Open the package first. 2. Remove one of the labels and carefully place it on the pest. 3. Moisturize it with saliva, the Aphthogel easily adheres to the pest. 4. The label stays on the pest for 25-30 minutes and then the rest is removed.(Swallowing the drug is not prohibited) 5. Repeat this operation 4 times a day. Use of mucoadhesive continues until complete recovery. The rate of pest diameter changes in the two intervention groups. Timepoint: Measuring the pest diameter on the first, second and third days. Method of measurement: Dental gauge. The amount of spontaneous pain in the two intervention groups. Timepoint: Measuring the amount of spontaneous pain on the first, second and third days. Method of measurement: VAS diagram describing the amount of pain. The amount of functional pain in the two intervention groups. Timepoint: Measurement of the amount of functional pain in the first, second and third days of lesion. Method of measurement: VAS diagram describing the amount of pain. Zanjan University of Medical Sciences Approved 2022-04-10 Ethics Committee of Zanjan University of Medical Sciences The headquarters of Zanjan University of Medical Sciences, at the beginning of Jomhuri Eslami Boulevard, Azadi Square, Zanjan Zanjan Zanjan Iran (Islamic Republic of)