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IRCT20240802062616N1 IRCT 2024-09-19 Mazandaran University of Medical Sciences Investigating the effect of c-Phycocyanin pure compound on mouth sores Evaluate the effectiveness of c-Phycocyanin mucoadhesive paste on recurrent aphthous stomatitis (RAS) 2024-09-17 anticipated 40 Complete https://irct.ir/trial/78300 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are distributed into two control and intervention groups with the help of random allocation software 2 and with the randomized block method of 2. Blocks will be considered as quadruplets (two people will be placed in each group in each block), Blinding description: Patients are distributed into two control and intervention groups using a randomized block method of 2 (each group includes 20 people). Code A of the intervention group received mucoadhesive containing phycocyanin and code B of the placebo control group received mucoadhesive without active ingredient. The conditions of the study are explained to the patients, but they do not know which medicine has the active ingredient. 3 Recurrent aphthous stomatitis. Intervention 1: Intervention group: They receive mucus glue three times a day (morning, noon and night). Intervention 2: Control group: receives a placebo. Yes - There is a plan to make this available What will be shared: After the completion of the results plan, it will be delivered in the form of a final report and electronically (on a CD) to the Research Vice-Chancellor and Faculty of Dentistry of Mazandaran University of Medical Sciences. When: The decision regarding the access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran Faculty of Medical Sciences, as well as the supervisor. To whom: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor Conditions: To present the final report and write the article Where to obtain: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor How to obtain: A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor Comments:
public Dr. Anahita Ghorbani
Khazar Boulevard, Tuba Dental Clinic
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 4894 aghorbani@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Anahita Ghorbani
Tuba Clinic, Khazar Street, Sari
Sari Iran (Islamic Republic of) 33971-48157 +98 911 151 3085 ‏anahita1802@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with minor recurrent stomatitis, patients with aphthous lesions on the lips and buccal mucosa, not suffering from systemic disease, not taking immunosuppressive drugs in the past month, not using dentures, not taking antibiotics. 18 years 60 years Both Exclusion criteria include people taking immunosuppressive drugs in the past month, people with systemic disease, people with syndromes such as Behcet's syndrome, where aphthous ulcers are one of its manifestations, patients with aphthous lesions in areas other than the lips and buccal mucosa, People with recurrent herpetiform stomatitis, People with major recurrent stomatitis, Patients with poor hygiene level, Pregnant women, Antibiotic users, Patients with dentures, People who use other drugs to treat plague and in general people who due to personal reasons or Social workers cannot continue to cooperate until the completion of the study. K12.0 Recurrent oral aphthae Treatment - Drugs Treatment - Drugs Intervention group: They receive mucus glue three times a day (morning, noon and night). Control group: receives a placebo. The amount of pain and recovery of recurrent aphthous lesions. Timepoint: Days 0 (start of study), 3, 5 and 7. Method of measurement: Determining the diameter of lesions using a metal caliper and measuring the intensity of pain using a visual analog scale (VAS). Mazandaran University of Medical Sciences Approved 2024-07-08 Ethics Committee of Mazandaran University of Medical Sciences Moalem Square, Building No. 2 of the University, Research Vice Chancellor Sari Mazandaran Iran (Islamic Republic of)