]>
IRCT20170430033722N4 IRCT 2021-07-16 Mazandaran University of Medical Sciences Assessment of Atorvastatin mucoadhesive effect on minor recurrent aphthous stomatitis RAS Assessment of Atorvastatin mucoadhesive effect on minor recurrent aphthous stomatitis 2021-04-04 anticipated 44 Complete https://irct.ir/trial/55258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be determined by random blocking method with 4 blocks and using the random number table of Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The allocation ratio of the samples will be (Allocation 1: 1) and they will be placed in two groups receiving atorvastatin and placebo mucoadhesives. Drugs will then be given to patients based on the blocks obtained and in the order of allocation, Blinding description: participants are not aware of the type of mucoadhesive used the examiner (the person measuring the size of the lesions) is also unaware of the type of mucoadhesive used. 3 Recurrent aphthous stomatitis. Intervention 1: Intervention group: Patients will be given 3 mucoadhesives containing 10 mg of atorvastatin daily for 10 days to use in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use. Intervention 2: Control group: Patients will be given 3 doses of non-drug adhesive (placebo) daily for 10 days so that they can use it in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use. 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 further information
public Maede Salehi Sarookolaei
Sari dentistry college, Khazar square
Sari Iran (Islamic Republic of) 4815733971 +98 11 3324 4014 salehimaede1165@gmail.com Mazandaran University of Medical Sciences scientific Dr Tahereh Molania
Dental clinic, Khazar Blvd, Khazar square
Sari Iran (Islamic Republic of) 4815733971 +98 11 3330 2908 T_molania117@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with recurrent aphthous stomatitis showing aphthous lesions in the lips and buccal mucosa No systemic disease Do not take immunosuppressive drugs for the past month Do not use dentures Do not take antibiotics 20 years 40 years Both Pregnant patients People who are not able to use mucoadhesive People with syndromes in which aphthous ulcers are manifestations (Behjat syndrome) the smokers People with autoimmune mucocutaneus lesions Patients with liver failure, myopathy and muscle problems Patients with allergies, hives and itchy skin and mucous membranes People who can not stay in the study due to personal or social reasons K12.0 Recurrent oral aphthae Prevention Placebo Intervention group: Patients will be given 3 mucoadhesives containing 10 mg of atorvastatin daily for 10 days to use in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use. Control group: Patients will be given 3 doses of non-drug adhesive (placebo) daily for 10 days so that they can use it in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use. The size of the erythematous halo around the aphthous lesion. Timepoint: 0 (Before intervention) and 3, 5 and 7 days after aphthous lesion. Method of measurement: Metal caliber. Patients' pain intensity. Timepoint: 0 (Before intervention) and 3, 5 and 7 days after aphthous lesion. Method of measurement: Visual Analog Scale (universal Pain Assessment Tool). Mazandaran University of Medical Sciences Approved 2021-01-05 Ethics Committee of Mazandaran University of Medical Sciences School of Dentistry, Mazandaran University of Medical Sciences, Sari, Khazar Square, next to Touba Complex sari Mazandaran Iran (Islamic Republic of)