]>
IRCT20241104063590N1 IRCT 2025-02-24 Mazandaran University of Medical Sciences Effect of postoperative low-level laser therapy on pain, edema, and trismus after impacted mandibular third molar surgery: a randomized clinical trial Effect of postoperative low-level laser therapy on pain, edema, and trismus after impacted mandibular third molar surgery: a randomized clinical trial 2025-03-30 anticipated 52 Complete https://irct.ir/trial/81678 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients undergoing mandibular wisdom tooth extraction surgery are randomly assigned to one of two intervention or control groups by coin tossing. Randomization is done in a simple and individual manner. Randomization is done for each patient individually and without regard to the randomization results of other patients, Blinding description: The laser will be used for all patients, but the laser will be turned off for the control group, so the patients will be blinded. The study investigator will not know the outcome of each patient’s assignment to each group. The outcome assessor who measures the study tests will not know the outcome of each patient’s randomization. The safety and data monitoring committee will not know the outcome of each patient’s assignment to each group. The data analyst will not know the outcome of each patient’s assignment to each group. N/A Condition 1: pain. Condition 2: trismus. Intervention 1: Intervention group: For the intervention group, a low-power laser with a specific wavelength (970 nm) and standard settings (power 200 mW) will be used after surgery. Photobiomodulation sessions will be performed for one week (day zero and one) and at specific intervals. The laser used is a Dentsply low-power laser device made in the United States. Intervention 2: Control group: The control group will receive standard postoperative treatment (such as anti-inflammatory drugs and painkillers). Acetaminophen 500 mg every 6 hours and amoxicillin every 8 hours for 5 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period starts 12 months after results are published. To whom: It will only be available to researchers working in academic and scientific institutions. Conditions: Only statistical analyses are permitted to verify the validity of the study conducted. Where to obtain: Applicants can send their request for access to data via email to mehdi_hashemi@sbmu.ac.ir. How to obtain: After receiving the request, the research team and study authors will review it and a response will be provided within one week. Comments:
public seyed mehdi hashemi sheykhAbadi
Deputy for Research and Technology Building, Moallem Square, Sari
Sari Iran (Islamic Republic of) 4817844718 +98 11 3325 7230 mehdi_hashemi@sbmu.ac.ir Mazandaran University of Medical Sciences scientific seyed mehdi hashemi sheykhAbadi
Deputy for Research and Technology Building, Moallem Square, Sari
Sari Iran (Islamic Republic of) 4817844718 +98 11 3325 7230 mehdi_hashemi@sbmu.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Having at least one impacted lower wisdom tooth Need for lower wisdom tooth surgery Written consent to participate in the study 18 years 40 years Both Presence of systemic and underlying diseases Pregnancy or breastfeeding Unusual complications during surgery (such as jaw bone fracture, jaw dislocation, etc.) Using anti-inflammatory drugs or strong painkillers R52 R25.2 pain not referable to any one organ or body region Cramp and spasm Treatment - Devices Treatment - Drugs Intervention group: For the intervention group, a low-power laser with a specific wavelength (970 nm) and standard settings (power 200 mW) will be used after surgery. Photobiomodulation sessions will be performed for one week (day zero and one) and at specific intervals. The laser used is a Dentsply low-power laser device made in the United States. Control group: The control group will receive standard postoperative treatment (such as anti-inflammatory drugs and painkillers). Acetaminophen 500 mg every 6 hours and amoxicillin every 8 hours for 5 days. Pain. Timepoint: Day of surgery - One day after surgery - One week after surgery. Method of measurement: It will be assessed using a scale (VAS) at specific intervals after surgery. Trismus. Timepoint: Day of surgery - One day after surgery - One week after surgery. Method of measurement: It will be assessed by measuring specific distances on the face (such as the distance from the angle of the jaw to the peak of the zygomatic bone). Mazandaran University of Medical Sciences Approved 2024-10-21 Research Ethics Committee of Mazandaran University of Medical Sciences and Health Services Deputy for Research and Technology Building, Moallem Square Sari Mazandaran Iran (Islamic Republic of)