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Assessment of Er:YAG Laser-Assisted Surgical Treatment in Medication-Related Osteonecrosis of the Jaw (MRONJ): A Clinical Trial

NCT07029815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-06-19

No results posted yet for this study

Summary

The aim of this study is assessing the effectiveness of the Er:YAG laser in relation to the use of conventional surgery in the treatment of drug-induced osteonecrosis of the jaws (MRONJ). The study compares two main treatments for advanced cases of MRONJ or cases that do not show improvement despite conservative or non-surgical treatment.

Conditions

  • Medication-Related Osteonecrosis of Jaw

Interventions

PROCEDURE

irradiation with Er:YAG laser

An Er:YAG laser (LightTouch, LightInstruments, Yokneam, Israel) was used with the following parameters: 400mJ (millijoules), 6W (Watt), 15Hz (Hertz), 5/8 water cooling, laser tip with a diameter of 800 microns. Tissue debridement continued until hard, healthy, lively bleeding bone was exposed, indicative of normal bone.

PROCEDURE

Tissue preparation

Rose-shaped rotary drills (8 mm diameter) were used with water cooling at a speed not exceeding 40.000 rpm. Tissue preparation limits were consistent with those used for the Er:YAG laser group.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Kinga Grzech-Leśniak, DDS, MS PhD · Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland and Department of Periodontics, School of Dentistry Virginia Commonwealth University, 12th St, Richmond, VA 23298, USA

  • Marzena Dominiak, Prof. dr hab n. med. · Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-08-01
Completion
2025-05-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07029815 on ClinicalTrials.gov