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IRCT20211206053290N1 IRCT 2023-04-22 Sanandaj University of Medical Sciences Therapeutic Efficacy of Pistacia atlantica essential oil in the treatment of Recurrent Aphthous Stomatitis referred to Kowsar hospitals of Sanandaj Therapeutic Efficacy of Pistacia atlantica essential oil in the treatment of Recurrent Aphthous Stomatitis referred to Kowsar hospitals of Sanandaj in 2022 2023-02-20 anticipated 100 Complete https://irct.ir/trial/60592 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample will be assigned to 2 groups at random, so that patients with the condition will be assigned to a double block (A and B) by the researcher. Then a package containing 100 cards with one of the letters A and B (50 each) is considered to randomly select a card from the package and enter one of the groups according to the Latin letter. In this way, 50 people are assigned to each group. Sampling is done in parallel in 2 groups until the number of samples is completed, Blinding description: Blinding (double-blind) means that both the participants and the researchers or the outcome assessors will not be aware of the random assignment of the study subjects to one of the intervention or control groups, because the random assignment based on blocking to one of the groups It was done with special numbers and using sealed envelopes, and receiving the medicine and placebo, considering that they are the same in color, shape, taste and smell, they are not able to know about the allocation of study groups. 3 Aphthous Stomatitis. Intervention 1: Intervention group: The intervention group will be prescribed Teriadent ointment. How use it is that, The gel will be applied topically 3 times a day (with an approximate weight of 200 mg containing 3 mg of essential oil) on the lesion on the swab for 20 to 30 seconds.(Product of Zhiran Daneshpojohan company). Intervention 2: Control group: The control group will be prescribed Teriadent ointment. How use it is that, The gel will be applied topically 3 times a day (with an approximate weight of 200 mg containing 3 mg of essential oil) on the lesion on the swab for 20 to 30 seconds. Yes - There is a plan to make this available What will be shared: All patient information will be kept confidential by researchers. Data analysis and article publishing will also be done. When: From 2023 and 1 year before the publication of the results To whom: Researcher. Conditions: The data file will be available as an article publication Where to obtain: The main performer How to obtain: Formal request to the Vice Chancellor for Research and Technology of the University and the main executor Comments:
public Dr. Jamal Amjadi
Pasdaran Ave
Sanandaj Iran (Islamic Republic of) 1344666177 +98 87 3366 4654 amjadijamal@yahoo.com Sanandaj University of Medical Sciences scientific Dr.Jamal Amjadi
Pasdaran Ave
Sanandaj Iran (Islamic Republic of) 6617713446 0098733611231 amjadijamal@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) No more than 2 days have passed since the onset of aphthous ulcers. Have not used any other treatment for their wounds before going to the clinic. Patients have completed the consent to participate in the trial. Be in the age group over 18 years. People with a clear history of plague should be reported at least twice a year. 18 years 65 years Both People are allergic to the compounds and drugs used in the trial. Failure to follow the recommended instructions during the study Patients with systemic diseases such as diabetes, asthma, renal and hepatic insufficiency, epilepsy, blood and glandular disorders as well as pregnant women Patients taking antibiotics or anti-inflammatory drugs for other reasons. ICD-10 K12 Aphthous stomatitis Treatment - Drugs Placebo Intervention group: The intervention group will be prescribed Teriadent ointment. How use it is that, The gel will be applied topically 3 times a day (with an approximate weight of 200 mg containing 3 mg of essential oil) on the lesion on the swab for 20 to 30 seconds.(Product of Zhiran Daneshpojohan company) Control group: The control group will be prescribed Teriadent ointment. How use it is that, The gel will be applied topically 3 times a day (with an approximate weight of 200 mg containing 3 mg of essential oil) on the lesion on the swab for 20 to 30 seconds. Follow-up time to observe changes and improvement in aphthous lesions will be on days zero (during the first visit to the doctor), 1 (first examination) on days 7 and 10 (follow-up) after starting treatment, which will be done by referring patients to the clinic. The studied variables include the number of wounds, the size of the wounds, the amount of pain and burning, and the amount of erythema and exudate. This information will be recorded each time the patient is examined in a special form along with the patient's demographic information. Timepoint: Follow-up time to observe changes and improvement in aphthous lesions will be on days zero (during the first visit to the doctor), 1 (first examination) on days 7 and 10 (follow-up) after starting treatment, which will be done by referring patients to the clinic. Method of measurement: Wound size will be measured by a special Williams dental probe. Also, the number of mouth ulcers will be counted at the beginning of the day and during the study period. The scale of burning and pain consists of a line of 10 cm, which means zero, no pain and 10 maximum pain. The patient determines the points that indicate pain, then from zero to that point will be measured and a numerical scale from one to 100 mm will be recorded.Pain intensity in patients will be measured based on the Visual Analog Scale (VAS). This pain scale represents a 10 cm line printed with markers at each end on a piece of paper. It is "painless" at one end and "worst pain" or "indescribable pain" at the other. The person places a cross × on the line to indicate the severity of their pain. A doctor then measures the line with a ruler to get a pain score.For children, pain scales using face images are commonly used. A child may express pain with pictures of eight different faces with different expressions. The child chooses a face that feels more in tune with their current level of pain. Sanandaj University of Medical Sciences Approved 2023-01-18 Ethics Committee of Kurdistan University of Medical Sciences Pasdaran Ave, In front of Shadi Hotel Sanandaj Kurdistan Iran (Islamic Republic of)