]>
IRCT20120101008585N16 IRCT 2022-12-04 Fars Province Governor Office The effect of photodynamic therapy on oral mucositis The effect of Indocyanine green mediated photodynamic therapy in combination with low level laser therapy on pain and size of chemotherapy induced oral mucositis 2022-12-21 anticipated 40 Complete https://irct.ir/trial/66570 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each block with 4 allocations, consisting of 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 40 participants (10 blocks). The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 40 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 the order of enrollment, Blinding description: One of the researchers will prescribe the treatment and another researcher will assess the outcome. Therefore, the researchers will be blind. The statistical analyzer will be blind to the type of treatment in each group. The outcome assessor, patients and statistical analyzer will be blind to the prescribed treatment. Both groups of patients will receive chlorhexidine and nystatin as routine treatment. The patients in the intervention group will receive low level laser, but the patients in control group will receive sham laser. 1-2 Chemotherapy induced oral mucositis. Intervention 1: Intervention group: In interventional group, photodynamic therapy will be started from emerging the first manifestation of mucositis induced by chemotherapy, once a week for 4 weeks. Indocyanine green will be used for photodynamic therapy and low level laser(LLL) will be applied for activation of this vital stain. After dilution of Indocyanine green (0.1 mg/ml), it will be applied to lesions and after ten minutes low level laser with wave length 808 nm and dose of 50 J/cm2 will be radiated on oral lesions of participants. Intervention 2: Control group: In the control group, after dilution of Indocyanine green(0.1mg/ml), it will be applied to lesions and after ten minutes patients will receive sham laser. 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) 71956-15878 +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) 71956-15878 +98 71 3631 9309 lavaeef@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients above 8 years old Patients with intact mucosa at the beginning of the study Patients with chemotherapy induced oral mucositis Patients signing the consent form 8 years 99 years Both Patients under chemotherapy for any reason except acute leukemia Patient who are allergic to the Indocyanine green stain Patients with diabetes mellitus Patients refusing to sign the consent form K12.3 Oral mucositis (ulcerative) Treatment - Other Placebo Intervention group: In interventional group, photodynamic therapy will be started from emerging the first manifestation of mucositis induced by chemotherapy, once a week for 4 weeks. Indocyanine green will be used for photodynamic therapy and low level laser(LLL) will be applied for activation of this vital stain. After dilution of Indocyanine green (0.1 mg/ml), it will be applied to lesions and after ten minutes low level laser with wave length 808 nm and dose of 50 J/cm2 will be radiated on oral lesions of participants. Control group: In the control group, after dilution of Indocyanine green(0.1mg/ml), it will be applied to lesions and after ten minutes patients will receive sham laser. The level of pain and disability. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14, 21, and 28 days after the start. Method of measurement: WHO index. Size of lesion. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14, 21, and 28 days after the start. Method of measurement: NCI Score. Fars Province Governor Office Approved 2022-09-12 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Science, Zand street, Shiraz, Fars Shiraz Fars Iran (Islamic Republic of)