Medication-Related Osteonecrosis of JawNCT07029815
Assessment of Er:YAG Laser-Assisted Surgical Treatment in Medication-Related Osteonecrosis of the Jaw (MRONJ): A Clinical Trial
A study testing irradiation with Er:YAG laser and Tissue preparation in people with Medication-Related Osteonecrosis of Jaw, run by Wroclaw Medical University at 1 site in Poland.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication-Related Osteonecrosis of Jaw
- What is being tested?
- irradiation with Er:YAG laser and Tissue preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2021to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- confirmed diagnosis of MRONJ
Who cannot join
- head and neck radiotherapy
- cases requiring hospital admission due to poor general condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Er:YAG (Yttrium-aluminium-garnet) 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.
- Conditions
- Medication-Related Osteonecrosis of Jaw
- Being tested
- irradiation with Er:YAG laser, Tissue preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irradiation with Er:YAG laserProcedure or surgery
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 preparationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with the Er:YAG laser | Experimental | Not described Receives: Procedure: irradiation with Er:YAG laser |
| Patients treated with the conventional surgery | Active comparator | Not described Receives: Procedure: Tissue preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Occurrence or absence of complications
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Feb 2021
- Primary completion1 Aug 2023
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication-Related Osteonecrosis of JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinga Grzech-Leśniak, DDS, MS PhD, 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, USAMarzena Dominiak, Prof. dr hab n. med., Study chair, Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029815
- Sponsor's protocol ID
- KB-27/2021
- Status last verified
- May 2025
- First submitted
- 2 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Er:YAG (Yttrium-aluminium-garnet) Laser-Assisted Surgical Treatment in Medication-Related Osteonecrosis of the Jaw (MRONJ): A Clinical Trial
- ClinicalTrials.gov ID
- NCT07029815
- Acronym / sponsor ID
- KB-27/2021
- Conditions
- Medication-Related Osteonecrosis of Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the Er:YAG laser | Experimental | Procedure: irradiation with Er:YAG laser |
| Patients treated with the conventional surgery | Active comparator | Procedure: Tissue preparation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed diagnosis of MRONJ
Key exclusion criteria (2 listed)
- head and neck radiotherapy
- cases requiring hospital admission due to poor general condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| irradiation with Er:YAG laserAn 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 or surgery | Patients treated with the Er:YAG laser |
| Tissue preparationRose-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. | Procedure or surgery | Patients treated with the conventional surgery |
Primary outcome
Complications
Time frame: Up to 6 months
Occurrence or absence of complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kinga Grzech-Leśniak, DDS, MS PhD 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. study chair
Dental Surgery Department, Wroclaw Medical University, Krakowska st. 26, 50-425 Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irradiation with Er:YAG laser and Tissue preparation in people with Medication-Related Osteonecrosis of Jaw, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.