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IRCT20120101008585N6 IRCT 2018-12-26 Shiraz University of Medical Sciences Effect of indocyanin green on denture stomatitis Evaluation of Indocyanine green mediated photodynamic therapy on grade and size of Denture stomatitis 2018-08-02 anticipated 48 Complete https://irct.ir/trial/32426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: 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: Participant will be blind to their treatment. Nystatin oral suspension will be prescribed in both groups. In the intervention group photodynamic therapy will be done at the same period.In the control group sham laser will be irradiated. Since patients do not know the on or off mode of applied laser and also since the assessor of parameters is different from the one who will apply laser, both participants in intervention group and the assessor will be blind. 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. Photodynamic therapy will be applied on denture stomatitis lesions in day 1 and 15. Topical indocyanin green (Ench industry company, Shandong, China) will be applied with micropipette on lesion and after 10 min, the lesion will be irradiated with a 810nm diode laser for 30sec (power: 300mW). Intervention 2: Control group: nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribe to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Topical indocyanin green (Ench industry company, Shandong, China) with micro pipette and sham laser irradiation will done in day 1 and 15. 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 3631 9309 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 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Edentulous denture-wearing patients with denture stomatitis 20 years no limit Both Immunosuppressive patient Diabetic patient Patient who used antibiotic, antifungal medication or corticosteroid during last 3 months Chemotherapy or radiotherapy B37.0 Candidal stomatitis Treatment - Other 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. Photodynamic therapy will be applied on denture stomatitis lesions in day 1 and 15. Topical indocyanin green (Ench industry company, Shandong, China) will be applied with micropipette on lesion and after 10 min, the lesion will be irradiated with a 810nm diode laser for 30sec (power: 300mW). Control group: nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribe to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Topical indocyanin green (Ench industry company, Shandong, China) with micro pipette and sham laser irradiation will done in day 1 and 15. Lesion size. Timepoint: Day 1 and 15. Method of measurement: Newton's classification. Candida colony count. Timepoint: Day 1 and 15. Method of measurement: CFU/ml colony count. Indocyanine green hypersensivity. Timepoint: Day 1 and 15. Method of measurement: clinical symptom of hypersensitivity. Shiraz University of Medical Sciences Approved 2018-07-29 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)