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

NCT ID: NCT07029815

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Medication-Related Osteonecrosis of Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients treated with the Er:YAG laser

Group Type EXPERIMENTAL

irradiation with Er:YAG laser

Intervention Type 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.

Patients treated with the conventional surgery

Group Type ACTIVE_COMPARATOR

Tissue preparation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of MRONJ

Exclusion Criteria

* head and neck radiotherapy
* cases requiring hospital admission due to poor general condition
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kinga Grzech-Leśniak, DDS, MS PhD

Role: STUDY_DIRECTOR

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.

Role: STUDY_CHAIR

Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland

Locations

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Wroclaw Medical University

Wroclaw, , Poland

Site Status

Countries

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Poland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KB-27/2021

Identifier Type: -

Identifier Source: org_study_id

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