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IRCT20200303046685N2 IRCT 2020-07-06 Esfahan University of Medical Sciences Evaluation of antifungal effect of Ganoderma in denture stomatitis Comparing the antifungal effect of Ganoderma gel and Clotrimazole gel in patients with denture stomatitis 2020-06-21 anticipated 60 Complete https://irct.ir/trial/47580 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method is simple random sampling. Randomization unit: individual. Randomization tool: Random number table. Among patients suffering from Denture stomatitis referred to Isfahan University of Medical Sciences, 60 patients who have been examined and met the eligibility criteria will enter the study and a number will be assigned to every patient. Then they will be divided into two groups using block randomization (block size=30) in the random allocation service software. For allocation concealment, sealed coded boxes with same size and weight will be used, Blinding description: All patients know about drugs used in the research but they don't know which treatment they will be given. The result evaluator clinically observes patients only on follow up sessions. Also the researcher doesn't know about randomization and type of drug each patient have received because the clinical observant is only responsible for drug distribution. 3 Denture ostomatitis. Intervention 1: Intervention group: patients using 5% Ganoderma 3 times a day by putting 5 cm of gel inside the denture. Mushroom has been bought then it has been extracted by Pharmacognosy section of Isfahan University of Medical Sciences and has been used to produce the gel. Intervention 2: Control group: patients using 1% Clotrimazole 3 times a day by putting 5 cm of gel inside the denture. Powder of Clotrimazole has been bought from Raha company then Pharmaceutics section of Isfahan university of medical science has made the gel. No - There is not a plan to make this available Justification or reason for not sharing IPD is Commitment to the principle of confidentiality of the patient’s record
public Fahimeh Pakravan
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3436 8793 pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Fahimeh Pakravan
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
Isfahan Iran (Islamic Republic of) 817473461 +98 31 3792 5515 Pakravan@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Users of acrylic complete removable denture in maxilla who shows signs of type 1 or 2 denture stomatitis. no limit no limit Both History of Anti fungal, Anti bacterial, Corticosteroid drugs usage in last month Hypersensitivity to Ganoderma or Clotrimazole Immune suppression disorders Alzheimer disease Neuromuscular disease Mental disorders and lack of cooperation Chemotherapy or radiotherapy of head and neck in present or past Treatment - Drugs Treatment - Drugs Intervention group: patients using 5% Ganoderma 3 times a day by putting 5 cm of gel inside the denture. Mushroom has been bought then it has been extracted by Pharmacognosy section of Isfahan University of Medical Sciences and has been used to produce the gel. Control group: patients using 1% Clotrimazole 3 times a day by putting 5 cm of gel inside the denture. Powder of Clotrimazole has been bought from Raha company then Pharmaceutics section of Isfahan university of medical science has made the gel. Pain. Timepoint: Before starting research, 7, 14 days afters using drug. Method of measurement: Visual analogue scale. Esfahan University of Medical Sciences Approved 2020-02-23 Ethics committee of Isfahan University of Medical Sciences Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard Isfahan Isfehan Iran (Islamic Republic of)