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IRCT20120101008585N14 IRCT 2022-03-28 Shiraz University of Medical Sciences Antifungal Effect of Punica granatum Mouthwash on Oral Candidiasis The Antifungal Effect of Punica granatum Mouthwash on Oral Candidiasis: a clinical trial 2022-04-21 anticipated 48 Complete https://irct.ir/trial/62264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 48 participants (12 blocks). The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 48 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment, Blinding description: The outcome assessor and statistical analyzer will be blind to the prescribed treatment. Nystatin oral suspension will be prescribed in both groups. In the intervention group, Punica granatum mouthwash will be added. Since the outcome analyzer will be different from the one who prescribed the mouthwashes, the outcome assessor will be blinded. 2-3 Denture stomatitis. Intervention 1: Intervention group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. In addition, Punica granatum mouthwash will be prescribed 3 times a day for 15 days. Intervention 2: Control group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Yes - There is a plan to make this available What will be shared: All collected data will be shared after deidentification of participants. When: 6 months after publication data will become available. To whom: The researchers in academic institutions. Conditions: The researchers in academic institutions. Where to obtain: The researchers in academic institutions can email responsible person and request information. How to obtain: The researchers in academic institutions can email responsible person and request information. Comments:
public Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3626 3193 lavaeef@sums.ac.ir Shiraz University of Medical Sciences scientific Fatemeh Lavaee
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7186781559 +98 71 3626 3193 lavaeef@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Edentulous denture-wearing patients with denture stomatitis 18 years no limit Both Immunosuppressive patient Diabetic patient The patient who used antibiotic, antifungal medication, or corticosteroid during the last 3 months patients under Chemotherapy or radiotherapy B37.0 Candidal stomatitis Treatment - Drugs Treatment - Drugs Intervention group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. In addition, Punica granatum mouthwash will be prescribed 3 times a day for 15 days. Control group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Lesion size. Timepoint: Day 1 and 15 and 30. Method of measurement: Newton's classification. Candida colony count. Timepoint: Day 1 and 15 and 30. Method of measurement: CFU/ml colony count. Shiraz University of Medical Sciences Approved 2019-07-07 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)