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IRCT20150613022697N13 IRCT 2023-03-05 Mashhad University of Medical Sciences Evaluating the effect of low-level laser versus ozone in patients with Medication-related osteonecrosis of the jaw who were treated with debridement surgery and Platelet-rich fibrin Evaluating the complementary treatment effect of low-level laser versus ozone in patients with MRONJ (Medication-related osteonecrosis of the jaw) who were treated with debridement surgery and PRF (Platelet-rich fibrin) 2023-04-04 anticipated 30 Complete https://irct.ir/trial/68399 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since the three groups are supposed to have the same sample size, the restricted randomization method and permuted block randomization will be used in this study. Random block units will usually be used to balance the number of samples assigned to each of the groups studied. The size of blocks will be selected randomly and there is an equal number of each group in each block. Creating a random sequence will be performed by computer software " Random Allocation Software". Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process, Blinding description: In this study, the outcome assessor will not be aware of the study groups. The assessor, the operator who delivers the checklist to the patient and completes the study checklist is not aware of the group assignment to prevent the complications. 3 Condition 1: Osteonecrosis. Condition 2: Pain in jaw. Condition 3: Soft tissue dehiscence. Intervention 1: Control group: Patients receive the usual and standard debridement surgery along with PRF (Platelet-rich fibrin). Intervention 2: Intervention group 1: In patients who have been treated with surgical debridement and PRF placement, in 10 sessions (3 days a week for 3 weeks and one session in the fourth week), (each session 2 syringes of 10 cc with a concentration of 25% in the lesion site with minimum distance of 2 cm and maximum of 4 cm from each other) will be subjected to ozone therapy with sedecal Ozone model serial number Ozt1077 made in Spain. Intervention 3: Intervention group 2: In patients who have been treated with surgical debridement and PRF placement, in 10 sessions (2 days a week for 5 weeks), (each session with a wavelength of 660 nm, 8 continuous points on the buccal surface and 8 continuous points on the lingual surface, each point will be irradiated for 15 seconds, then this process is repeated with a wavelength of 810 nm) laser therapy is performed with a THOR diode laser made in England and a power of 200 milliwatts. Yes - There is a plan to make this available What will be shared: All collected data would be shared for all researchers after the participants were unidentified. When: The access to data will be started 6 months after publication. To whom: The data would only be available for people working in academic institutions. Conditions: It is allowed to use the data for meta-analysis and systematic reviews. Where to obtain: The data can be obtained via email, from the corresponding researcher (Dr Sahand Samieerad). E-mail: samieerads@mums.ac.ir How to obtain: The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission. Comments:
public Sahand Samieerad
Oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences scientific Sahand Samieerad
Oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 samieerads@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with Medication-related osteonecrosis of the jaw, MRONJ stage 2, with pain and pus discharge No history of previous MRONJ treatment Absence of pathological fracture during study entry 18 years 80 years Both Pregnant patients The impossibility of frequent visits for complementary treatment sessions (ozone or laser) Radiotherapy during the treatment process Occurrence of pathological fracture in the jaw in the affected area Dissatisfaction with continuing the study M87.1 K10.9 M79.9 Osteonecrosis due to drugs Disease of jaws, unspecified Soft tissue disorder, unspecified Treatment - Surgery Treatment - Drugs Treatment - Other Control group: Patients receive the usual and standard debridement surgery along with PRF (Platelet-rich fibrin) Intervention group 1: In patients who have been treated with surgical debridement and PRF placement, in 10 sessions (3 days a week for 3 weeks and one session in the fourth week), (each session 2 syringes of 10 cc with a concentration of 25% in the lesion site with minimum distance of 2 cm and maximum of 4 cm from each other) will be subjected to ozone therapy with sedecal Ozone model serial number Ozt1077 made in Spain Intervention group 2: In patients who have been treated with surgical debridement and PRF placement, in 10 sessions (2 days a week for 5 weeks), (each session with a wavelength of 660 nm, 8 continuous points on the buccal surface and 8 continuous points on the lingual surface, each point will be irradiated for 15 seconds, then this process is repeated with a wavelength of 810 nm) laser therapy is performed with a THOR diode laser made in England and a power of 200 milliwatts Amount of jaw pain in the specified time period. Timepoint: 1, 3, 6 and 12 months after the intervention. Method of measurement: Visual Analogue Scale (VAS) in checklist. Soft tissue healing. Timepoint: 1, 3, 6 and 12 months after the intervention. Method of measurement: Appropriate soft tissue healing was defined when no dehiscence occurred. Infection. Timepoint: 1, 3, 6 and 12 months after the intervention. Method of measurement: Any sign of pus or fistula tract in treatment area. Mashhad University of Medical Sciences Approved 2023-02-13 Ethics committee of Mashhad University of Medical Science Ghoreishi building, Daneshghah avenue Mashhad Razavi Khorasan Iran (Islamic Republic of)