Medication Related Osteonecrosis of the JawREG-MRONJ-1NCT06984107
MRONJ and Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®)
A study testing MRONJ resection plus PN+HA in people with Medication Related Osteonecrosis of the Jaw, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Related Osteonecrosis of the Jaw
- What is being tested?
- MRONJ resection plus PN+HA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients older than 18 years
- Provided informed consent
- MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
- Need to undergo surgical treatment of MRONJ
Who cannot join
- Patients with history of head and neck radiotherapy
- Neurological and psychiatric conditions
- Pregnancy
- MRONJ stage 3 diagnosis
- Patients who will receive a re-treatment for MRONJ
- Patients with general contraindication for oral surgery
- Patients unable to attend the out-patients visits scheduled by the protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)
- Being tested
- MRONJ resection plus PN+HA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRONJ resection plus PN+HADevice
Surgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure.
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection plus polynucleotides and hyaluronic acid (PN+HA) | Experimental | Surgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure. Receives: Device: MRONJ resection plus PN+HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 7 days after surgical treatment
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 14 days after surgical treatment
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 21 days after surgical treatment
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 3 months after surgical treatment
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 6 months after surgical treatment
Clinical wound healing (modified Landry Healing Index)
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Measured: 12 months after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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 the JawStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlo Lajolo, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984107
- Sponsor's protocol ID
- 7475
- Acronym
- REG-MRONJ-1
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Application of Polynucleotides-Hyaluronic Acid Hydrogel (Regenfast®) for the Surgical Treatment of Medication-related Osteonecrosis of the Jaws (MRONJ): a Pilot Study
- ClinicalTrials.gov ID
- NCT06984107
- Acronym / sponsor ID
- REG-MRONJ-1 / 7475
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 22 May 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.
Several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of MRONJ. Supportive therapies are therefore needed to help tissues wound healing. The primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for MRONJ with intraoperative application of a gel based on polynucleotides and hyaluronic acid (PN+HA) (Regenfast®)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical resection plus polynucleotides and hyaluronic acid (PN+HA) | Experimental | Device: MRONJ resection plus PN+HASurgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Provided informed consent
- MRONJ stage 1 and stage 2 diagnosis, in accordance to SICMF-SIPMO classification
- Need to undergo surgical treatment of MRONJ
Key exclusion criteria (7 listed)
- Patients with history of head and neck radiotherapy
- Neurological and psychiatric conditions
- Pregnancy
- MRONJ stage 3 diagnosis
- Patients who will receive a re-treatment for MRONJ
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 |
|---|---|---|
| MRONJ resection plus PN+HASurgical management will be performed by reflecting a full-thick flap to expose the entire affected area, followed by removal of necrotic bone until a vital, unaffected bony margin will be obtained. After bone resection, the PN+HA (Regenfast®) will be applied on the residual bone surface. Wound management will be done via primary closure. | Device | Surgical resection plus polynucleotides and hyaluronic acid (PN+HA) |
Primary outcome
Clinical wound healing (modified Landry Healing Index)
Time frame: 7 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
Time frame: 14 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
Time frame: 21 days after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
Time frame: 3 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
Time frame: 6 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Clinical wound healing (modified Landry Healing Index)
Time frame: 12 months after surgical treatment
The clinical wound healing of the site will be assessed throughout the modified Landry Healing Index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
Related trials for Medication Related Osteonecrosis of the Jaw
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Not yet recruiting
Autologous Platelet Concentrates on the Healing of Extraction Sockets
Medication-related Osteonecrosis of the Jaw
Recruiting
Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
Medication Related Osteonecrosis of the Jaw
Active, not recruiting
Topical Oxygen Therapy for BRONJ
Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ), Oxygen
Not yet recruitingObservational study
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Medication-related Osteonecrosis of the Jaw (MRONJ)
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.
Carlo Lajolo principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing MRONJ resection plus PN+HA in people with Medication Related Osteonecrosis of the Jaw, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlo Lajolo (+393401004585, carlo.lajolo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical wound healing (modified Landry Healing Index) (time frame: 7 days after surgical treatment). The study lists 6 primary outcomes in all. 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 29 May 2025.