]>
IRCT20110428006322N2 IRCT 2019-10-17 Shiraz University of Medical Sciences probiotic on oral aphtus ulcers RAS or recurrent aphtus stomatitis Evaluation of therapeutic effect of pro biotic medication on oral recurrent aphtus ulcers 2019-07-23 anticipated 40 Complete https://irct.ir/trial/39651 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: clustered block randomization ,To ensure that exactly the same number of participants were placed in the intervention and control groups at regular intervals but at equal intervals, we considered the size of each block as 10 individuals. For example, one type of treatment or intervention will be occurred to the first block and the other intervention or treatment to the second block and again the same cycle until the last block. In this study we have 3 to blocks that include 10 individuals, Blinding description: In this study, patients and assessors or examiners are not aware of the type of treatment provided. The patient receives treatment from the beginning, which is unclear whether the treatment is new or the standard treatment (on the other hand) and the examiner does not need to know what medicine the patient has used, it only records the information. 2-3 oral recurrent aphtus ulcer. Intervention 1: Intervention group: Treatment with probiotic product or probiotic products from Lactobacillus routeri is administered in a gel-sol form, which patients put in the mouth on the lesion and should not swallow the drug. The drug is formulated in the Biotechnology and Pharmacotechnics department of Shiraz Pharmacy School and is not a mass production or drug owned by a particular pharmaceutical company. The product should be applied 3 times daily to the oral lesion for at least 2-3 minutes for 10 days. The product is based on the drug protocols and approved drug standards at the School of Pharmacy and its route of manufacture is part of the process of this study. The content of this drug is merely a probiotic product, and the drug is in the form of a gel-sol form, a relatively diluted state that makes it easier for the patient to use the drug. Use of probiotic products in the pharmaceutical process Considering that they are used in many nutritional supplement products and offer immune-enhancing or immune-enhancing roles, they are considered safe products in most pharmaceutical supplements. Intervention 2: Control group: receive standard analgesic treatment for treatment ( Standard compound oral mouthwash with analgesic effect) , For the control group patients receive conventional topical analgesics, including Diphenhydramine syrup + Aluminum Mg suspension (both manufactured by Iran Pakhsh Pharmacopoeia Iran) with a ratio of one to one, and a similar container is given to the intervention group. The drug is prescribed 3 times a day for 10 days. Yes - There is a plan to make this available What will be shared: In this study, due to the confidentiality of the individual data of the participants, only the executive protocol, data analysis method, and general plan information are shared in the article. When: starting 6 months after publication To whom: this only available for people working in academic institutions Conditions: only for research propose Where to obtain: email address How to obtain: Send an email to the planner and contact person to receive the required information. In the absence of the problem, the information required will be less than 2 weeks Comments: no
public Mostafa Rezaee
Ghasr-e-Dasht St., Corner of Mehr St., Shiraz Dental School
Shiraz Iran (Islamic Republic of) 1587871956 +98 71 3628 9917 rezaim@sums.ac.ir Shiraz University of Medical Sciences scientific Mostafa Rezaee
Ghasr-e-Dasht St., Corner of Mehr St., Shiraz Dental School
Shiraz Iran (Islamic Republic of) 1587871956 +98 71 3628 9917 rezaim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) patients with oral aphtus ulcers between 15 -80 years old. patients with oral aphtus ulcers without any systemic medication during last 6 months. patients with one to three oral aphtus ulcers in their mouths Patients with oral lesions that do not have a day off at the beginning of the lesion (the lesion is on the first day of appearance) Patients with oral lesions that do not have a history of rheumatologic disease, GI disease, renal disease, and iron deficiency anemia. no limit no limit Both Patients with oral aphtus lesions that have had a lesion more than one day. pregnant patients Patients with diffuse oral lesions and more than 3 concurrent lesions Patients who do not have the opportunity to travel for frequent or repeated examinations. K12 Stomatitis and related lesions Treatment - Drugs Treatment - Drugs Intervention group: Treatment with probiotic product or probiotic products from Lactobacillus routeri is administered in a gel-sol form, which patients put in the mouth on the lesion and should not swallow the drug. The drug is formulated in the Biotechnology and Pharmacotechnics department of Shiraz Pharmacy School and is not a mass production or drug owned by a particular pharmaceutical company. The product should be applied 3 times daily to the oral lesion for at least 2-3 minutes for 10 days. The product is based on the drug protocols and approved drug standards at the School of Pharmacy and its route of manufacture is part of the process of this study. The content of this drug is merely a probiotic product, and the drug is in the form of a gel-sol form, a relatively diluted state that makes it easier for the patient to use the drug. Use of probiotic products in the pharmaceutical process Considering that they are used in many nutritional supplement products and offer immune-enhancing or immune-enhancing roles, they are considered safe products in most pharmaceutical supplements. Control group: receive standard analgesic treatment for treatment ( Standard compound oral mouthwash with analgesic effect) , For the control group patients receive conventional topical analgesics, including Diphenhydramine syrup + Aluminum Mg suspension (both manufactured by Iran Pakhsh Pharmacopoeia Iran) with a ratio of one to one, and a similar container is given to the intervention group. The drug is prescribed 3 times a day for 10 days. The size of the lesions in millimeters. Timepoint: determination at 1,3,5 and 7 days. Method of measurement: size determination by ruler. Severity of burning and pain based on visual analogue score (VAS) (score between 0-10). Timepoint: determination at 1,3,5 and 7 days. Method of measurement: Evaluation by VAS method and numerical expression of pain and burning intensity. Duration of recovery in terms of number of days. Timepoint: daily check for seven days. Method of measurement: Improvement of clinical symptoms, absence of oral lesions and complete relief of burning and pain. Shiraz University of Medical Sciences Approved 2019-09-08 Ethics committee of Shiraz University of Medical Sciences Ghasr-e-Dasht St., Corner of Mehr St., Shiraz Dental School Shiraz Fars Iran (Islamic Republic of)