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Completed

NCT Number: NCT07029815

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

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.

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Key information

Conditions

Medication-Related Osteonecrosis of Jaw

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wroclaw Medical University

Wroclaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed diagnosis of MRONJ

Exclusion criteria

  • head and neck radiotherapy
  • cases requiring hospital admission due to poor general condition

Treatment and study plan

irradiation with Er:YAG laser

Procedure

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.

Tissue preparation

Procedure

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.

Primary outcomes

  1. Complications

    Time frame: Up to 6 months

    Occurrence or absence of complications

Other outcomes

  1. Severity of Osteonecrosis

    Time frame: 3 and 6 months after treatment.

    Incidence of grade II/III necrosis or no severe necrosis

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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