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New surgical tool may ease recovery for jaw bone disease patients

NCT ID NCT06622421

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two surgical techniques for treating medication-related osteonecrosis of the jaw (MRONJ), a condition where jawbone dies due to certain drugs. Thirty-four adults with stage 1 or 2 MRONJ will be randomly assigned to receive either traditional rotary instrument surgery or newer piezoelectric surgery. The main goal is to see which method causes less discomfort after surgery, with follow-up over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Piezoelectric surgery device
What this could lead to
If successful, this could show that piezoelectric surgery causes less pain and faster recovery for patients with jaw bone death caused by certain medications.
What could go wrong
This is a small, early-stage trial with only 34 participants, so results may not apply to everyone. The main goal is comfort, not a cure, and the condition can still return.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to understand the information provided and to give free consent; * Age greater than 18 years at the time of diagnosis; * Diagnosis of stage 1 or stage 2 MRONJ, according to the SICMF-SIPMO classification \[1\]; * Need for surgical treatment of MRONJ. Exclusion Criteria: * Patients with a previous history of radiotherapy in the head and neck area; * Patients with psychiatric disorders; * Women of childbearing age * Patients in stages of MRONJ other than stage 1 and 2; * Patients undergoing retreatment of MRONJ; * Patients with general medical contraindications for oral surgery procedures; * Patients unable to attend the outpatient visits required by the protocol.

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Conditions

The condition(s) this trial relates to.

Bisphosphonate-Associated Osteonecrosis of the Jaw osteonecrosis osteonecrosis of the jaw

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bisphosphonate-associated osteonecrosis of the jaw Osteonecrosis due to drug Osteonecrosis of the jaw

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Catholic University

    Roma, 00168, Italy

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Other studies related to the condition(s) this trial covers.