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IRCT20221224056905N1 IRCT 2023-01-17 Artesh University of Medical Sciences Effects of phototherapy in improving periodontal status in cancer patients Investigating the adjunctive effects of phototherapy in improving periodontal status in cancer patients during chemotherapy 2023-01-20 anticipated 20 Complete https://irct.ir/trial/67569 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Covariate Adaptive Randomization (Minimization) Randomization Unit: Stratified Randomization tool: R statistical software (CARAT package) Making random sequence: In this method, the first participant is randomly assigned to one of the groups, and the next participants are assigned to a group in order to balance the allocation according to the predetermined covariate variables. Allocation concealment: using numbered, sealed, and opaque envelopes, Blinding description: According to the specific conditions of cancer patients, they will be fully informed about the type of intervention. Due to the nature of the intervention (photobiomodulation + SRP vs. SRP alone), the main researcher who is in charge of the intervention is also aware of the type of intervention. However, a separate blinded investigator is considered for accurate measurement of periodontal parameters. N/A periodontal disease. Intervention 1: Intervention group: In a 14-day period of chemotherapy, patients after receiving routine periodontal treatment (SRP), one day between and at the end of a period of chemotherapy with the help of a laser with a wavelength of 630 nm and an energy density of 2 J/cm2 (for the purpose of photobiomodulation) involved and non-involved areas of the mouth will be irradiated. In time intervals of 0 days, 7 days, and 14 days after starting chemotherapy period, the areas inside the patient's mouth will be assessed for changes in periodontal parameters. Intervention 2: Control group: In a 14-day period of chemotherapy, these patients will receive only routine periodontal treatment (SRP). Yes - There is a plan to make this available What will be shared: All data can be shared upon request. When: 2024 - Q1 To whom: For researchers only Conditions: Not Applicable Where to obtain: Email: Parsafir2@gmail.com How to obtain: Obtaining permission from the publisher and journal in case of publishing the article Comments:
public Parsa Firoozi
No. 629, 1st floor, Bostan 8, Ansarieh, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4515745711 +98 902 251 9330 parsafir2@gmail.com Artesh University of Medical Sciences scientific Reza Fekrazad
AJA University of Medical Sciences, School of Dentistry, Misaq Complex, East 13th Street, Ajudaniyeh, Tehran, Iran
Tehran Iran (Islamic Republic of) 1111111111 +98 912 314 3138 rezafekrazad@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) presence of periodontal disease at least in one tooth Age < 65 years no limit 65 years Both Pregnancy or lactating Medication (i.e., antibiotics) affecting periodontal status Not receiving routine periodontal treatment (SRP) in the last 6 months K05 Gingivitis and periodontal diseases Treatment - Other Treatment - Other Intervention group: In a 14-day period of chemotherapy, patients after receiving routine periodontal treatment (SRP), one day between and at the end of a period of chemotherapy with the help of a laser with a wavelength of 630 nm and an energy density of 2 J/cm2 (for the purpose of photobiomodulation) involved and non-involved areas of the mouth will be irradiated. In time intervals of 0 days, 7 days, and 14 days after starting chemotherapy period, the areas inside the patient's mouth will be assessed for changes in periodontal parameters. Control group: In a 14-day period of chemotherapy, these patients will receive only routine periodontal treatment (SRP). Plaque Index. Timepoint: Baseline, 7, 14 days after starting chemotherapy period. Method of measurement: The plaque index quantitatively assesses the amount of dental plaque visible on the surfaces of all teeth, except the third molars. Gingival Index. Timepoint: Baseline, 7, 14 days after starting chemotherapy period. Method of measurement: The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. Bleeding on probing (BoP). Timepoint: Baseline, 7, 14 days after starting chemotherapy period. Method of measurement: Visual evaluation of bleeding. Pain/Burning. Timepoint: Baseline, 7, 14 days after starting chemotherapy period. Method of measurement: Visual Analogue Scale. Probing Depth. Timepoint: Baseline, 7, 14 days after starting chemotherapy period. Method of measurement: The distance measured from the base of the pocket to the most apical point on the gingival margin. Artesh University of Medical Sciences Approved 2022-12-17 Ethics committee of AJA University of Medical Sciences AJA University of Medical Sciences, School of Dentistry, Misaq Complex, East 13th Street, Ajudaniyeh, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)