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

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2023
INTERVENTION: 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. CONDITION: Condition 1: Osteonecrosis. Condition 2: Pain in jaw. Condition 3: Soft tissue dehiscence. ; Osteonecrosis due to drugs ; Disease of jaws, unspecified ; Soft tissue disorder, unspecified K10.9 M79.9 M87.1 PRIMARY OUTCOME: 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. SECONDARY OUTCOME: Infection. Timepoint: 1, 3, 6 and 12 months after the intervention. Method of measurement: Any sign of pus or fistula tract in treatment area. INCLUSION CRITERIA: 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
Epistemonikos ID: 4cb880f9572f780a47f55072d4e6f3592f7924b1
First added on: Feb 20, 2024