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Study aim:
Evaluating the complementary treatments of ozone therapy and PRF placement compared to laser therapy and PRF placement
Design:
A clinical trial with a control group, with parallel groups, single-blinded, randomized, phase 3 on 30 patients. The outcome assessor will not be aware of the study groups. Block randomization will be done by the computer software "Random Allocation Software".
Settings and conduct:
Oral and maxillofacial surgery department of Qaem hospital, Mashhad. The outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria:
The inclusion criteria includes: 1. All patients with Medication-related osteonecrosis of the jaw, MRONJ stage 2, with pain and pus discharge 2. No history of previous MRONJ treatment 3. Absence of pathological fracture during study entry; The Exclusion criteria includes: 1. Pregnant patients 2. The impossibility of frequent visits for complementary treatment sessions (ozone or laser) 3. Radiotherapy during the treatment process 4. Occurrence of pathological fracture in the jaw in the affected area 5. Dissatisfaction with continuing the study.
Intervention groups:
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) 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) laser therapy is performed with a THOR diode laser made in England and a power of 200 milliwatts.
Main outcome variables:
Amount of jaw pain in the specified time period;
Soft tissue healing;
Infection