Osteonecrosis of the JawPeRFOrMandNCT06419010
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
A study testing Surgery with the use of L-PRF and Standard surgery in people with Osteonecrosis of the Jaw, run by University Hospital, Toulouse at 7 sites in France.
Trial summary
Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis of the Jaw
- What is being tested?
- Surgery with the use of L-PRF and Standard surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2026to May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia;
- Affiliates or beneficiaries of a social security scheme.
- Having given free and informed written consent.
Who cannot join
- Presence of a maxillo-mandibular neoplastic lesion;
- Presence of several MRONJ lesions;
- History of cervico-facial radiotherapy;
- Contraindication to general anesthesia;
- Reduced life expectancy (estimated at less than 6 months).
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
University Hospital - Centre François-Xavier Michelet
Bordeaux
Mathieu BONDAZ, MD, 05 56 79 56 79 ext. +33, mathieu.bondaz@chu-bordeaux.fr
Mathieu BONDAZ, MD
University Hospital - Groupe hospitalier Pellegrin
Bordeaux
Jean-Christophe FRICAIN, MD, 05 56 79 56 79 ext. +33, jean-christophe.fricain@u-bordeaux.fr
Jean-Christophe FRICAIN, MD
University Hospital
Limoges
Julie USSEGLIO, MD, 05 55 05 61 20 ext. +33, julie.usseglio@chu-limoges.fr
Julie USSEGLIO, MD
University Hospital Gui de CHAULIAC
Montpellier
Marie DE BOUTRAY, MD, 04 67 33 68 03 ext. +33, m-deboutray@chu-montpellier.fr
Marie DE BOUTRAY, MD
University Hospital Pitié-Salpêtrière
Paris, 75013
Géraldine LESCAILLE, MD, 01 42 17 84 16 ext. +33
Géraldine LESCAILLE, MD
University Hospital
Toulouse, 31000
Franck DELANOE, MD, 05 61 77 74 76 ext. +33, delanoe.f@chu-toulouse.fr
Franck DELANOE, MD
University Hospital
Toulouse
Clément CAMBRONNE, MD, 06 78 18 54 78 ext. +33, cambronne.c@chu-toulouse.fr
Clément CAMBRONNE, MD
About this study
Official title: Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial
Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing.
Read the detailed description
Resulting in bone loss, infection, pain or discomfort, the presence of MRONJ decreases the quality of life of patients. There isn't any consensus about the treatment modalities for MRONJ, nor about its main goals. Traditionally, therapeutics only aimed to control and prevent the progression of the disease, but recent studies suggest that a whole resolution can currently be expected, especially from surgical therapies. These, when indicated, are not only intended for the removal of the pathological tissue, but above all for an hermetic mucosal healing, preventing secondary infection of the underlying bone.
The L-PRF (Leukocyte- and Platelet-Rich Fibrin) is a second-generation APC, produced in a strictly autologous way, by extemporaneous centrifugation of the patient's own blood. A fibrin clot, containing leukocytes and thrombocytes, is thereby isolated and transformed into membranes by compression. Their appliance to the surgical site allows a slow release of growth factors and cytokines with a positive effect on the revascularization of the wound.
Unfortunately, scientific evidence of their efficiencies is lacking. Therefore, a protocol of randomized clinical trial is proposed, aimed at evaluating the effect of the adjunction of APC to surgical procedures on the complete mucosal healing and thus the resolution of the MRONJ.
The control treatment strategy consists of the complete removal of the necrotic bone, in bleeding margins, followed by a tension-free and hermetic closure. In the test group, suturing will be preceded by the application of L-PRF membranes under the wound.
Patients will be followed for 6 months, during which the maintain of wound closure will be monitored. An evaluation of pain, health-related quality of life and oral health-related quality of life, will also be reported, such as the occurrence of adverse events.
- Conditions
- Osteonecrosis of the Jaw
- Being tested
- Surgery with the use of L-PRF, Standard surgery
- Keywords
- therapeutics, surgical, autologous platelet concentrates, Platelet-Rich Fibrin, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with the use of L-PRFProcedure or surgery
The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes
Standard surgeryProcedure or surgery
The standard surgical treatment, taking place in the operating room under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will benefit from surgery with the use of L-PRF. Receives: Procedure: Surgery with the use of L-PRF |
| Control group | Other | Patients will benefit from standard surgical treatment. Receives: Procedure: Standard surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of the use of L-PRF (platelet-rich fibrin)during the surgical treatment of Medication-Related Osteonecrosis of the Jaw, compared to surgical treatment alone, on complete mucosal healing.
Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the American Association of Oral and Maxillofacial Surgeons classification.
Measured: 6 months postoperatively
Secondary outcomes (12)
Medication-Related Osteonecrosis of the Jaw stage - Month 1
Evaluation and comparison between the 2 groups of the evolution of the Medication-Related Osteonecrosis of the Jaw stage - (improvement, stability, worsening).
Measured: 1 month postoperatively
Medication-Related Osteonecrosis of the Jaw stage - Month 3
Evaluation and comparison between the 2 groups of the evolution of the Medication-Related Osteonecrosis of the Jaw stage - (improvement, stability, worsening).
Measured: 3 months postoperatively
Medication-Related Osteonecrosis of the Jaw stage - Month 6
Evaluation and comparison between the 2 groups of the evolution of the Medication-Related Osteonecrosis of the Jaw stage - (improvement, stability, worsening).
Measured: 6 months postoperatively
the postoperative pain - Month 1
Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable).
Measured: 1 month postoperatively
the postoperative pain - Month 3
Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable).
Measured: 3 months postoperatively
the postoperative pain - Month 6
Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable).
Measured: 6 months postoperatively
health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF
Overall quality of life will be assessed by the WHOQOL-BREF questionnaire (World Health Organization Quality of Life)
Measured: 1 month postoperatively
health-related quality of life - Month 1 - OHIP-14 (Oral Health Impact Profile-14)
oral health-related quality of life will be assessed via the OHIP-14 (Oral Health Impact Profile-14) questionnaire.
Measured: 1 month postoperatively
health-related quality of life - Month 3 WHOQOL-BREF (World Health Organization Quality of Life )
Overall quality of life will be assessed by the WHOQOL-BREF questionnaire (World Health Organization Quality of Life ) and oral health-related quality of life will be assessed via the OHIP-14 questionnaire(Oral Health Impact Profile-14).
Measured: 3 months postoperatively
health-related quality of life - Month 3 Oral health-related quality OHIP-14 (Oral Health Impact Profile-14)
Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 (Oral Health Impact Profile-14) questionnaire.
Measured: 3 months postoperatively
health-related quality of life - Month 6 WHOQOL-BREF (World Health Organization Quality of Life )
Overall quality of life will be assessed by the WHOQOL-BREF questionnaire
Measured: 6 months postoperatively
health-related quality of life - Month 6 - OHIP-14 (Oral Health Impact Profile-14)
Oral health-related quality of life will be assessed via the OHIP-14 questionnaire (Oral Health Impact Profile-14).
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startNov 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteonecrosis of the JawStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire VILLEPINTE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419010
- Sponsor's protocol ID
- RC31/21/0165
- Acronym
- PeRFOrMand
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06419010
- Acronym / sponsor ID
- PeRFOrMand / RC31/21/0165
- Conditions
- Osteonecrosis of the Jaw
- Keywords
- therapeutics, surgical, autologous platelet concentrates, Platelet-Rich Fibrin, PRF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 17 May 2024 (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.
Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing.
Detailed description
Resulting in bone loss, infection, pain or discomfort, the presence of MRONJ decreases the quality of life of patients. There isn't any consensus about the treatment modalities for MRONJ, nor about its main goals. Traditionally, therapeutics only aimed to control and prevent the progression of the disease, but recent studies suggest that a whole resolution can currently be expected, especially from surgical therapies. These, when indicated, are not only intended for the removal of the pathological tissue, but above all for an hermetic mucosal healing, preventing secondary infection of the underlying bone.
The L-PRF (Leukocyte- and Platelet-Rich Fibrin) is a second-generation APC, produced in a strictly autologous way, by extemporaneous centrifugation of the patient's own blood. A fibrin clot, containing leukocytes and thrombocytes, is thereby isolated and transformed into membranes by compression. Their appliance to the surgical site allows a slow release of growth factors and cytokines with a positive effect on the revascularization of the wound.
Unfortunately, scientific evidence of their efficiencies is lacking. Therefore, a protocol of randomized clinical trial is proposed, aimed at evaluating the effect of the adjunction of APC to surgical procedures on the complete mucosal healing and thus the resolution of the MRONJ.
The control treatment strategy consists of the complete removal of the necrotic bone, in bleeding margins, followed by a tension-free and hermetic closure. In the test group, suturing will be preceded by the application of L-PRF membranes under the wound.
Patients will be followed for 6 months, during which the maintain of wound closure will be monitored. An evaluation of pain, health-related quality of life and oral health-related quality of life, will also be reported, such as the occurrence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Surgery with the use of L-PRFPatients will benefit from surgery with the use of L-PRF. |
| Control group | Other | Procedure: Standard surgeryPatients will benefit from standard surgical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia;
- Affiliates or beneficiaries of a social security scheme.
- Having given free and informed written consent.
Key exclusion criteria (5 listed)
- Presence of a maxillo-mandibular neoplastic lesion;
- Presence of several MRONJ lesions;
- History of cervico-facial radiotherapy;
- Contraindication to general anesthesia;
- Reduced life expectancy (estimated at less than 6 months).
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 |
|---|---|---|
| Surgery with the use of L-PRFThe study protocol is the same as the standard surgery one but with additional use of L-PRF membranes | Procedure or surgery | Experimental group |
| Standard surgeryThe standard surgical treatment, taking place in the operating room under general anesthesia | Procedure or surgery | Control group |
Primary outcome
Evaluation of the efficacy of the use of L-PRF (platelet-rich fibrin)during the surgical treatment of Medication-Related Osteonecrosis of the Jaw, compared to surgical treatment alone, on complete mucosal healing.
Time frame: 6 months postoperatively
Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the American Association of Oral and Maxillofacial Surgeons classification.
12 secondary outcomes
Medication-Related Osteonecrosis of the Jaw stage - Month 1
Time frame: 1 month postoperatively
Medication-Related Osteonecrosis of the Jaw stage - Month 3
Time frame: 3 months postoperatively
Medication-Related Osteonecrosis of the Jaw stage - Month 6
Time frame: 6 months postoperatively
the postoperative pain - Month 1
Time frame: 1 month postoperatively
the postoperative pain - Month 3
Time frame: 3 months postoperatively
the postoperative pain - Month 6
Time frame: 6 months postoperatively
health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF
Time frame: 1 month postoperatively
health-related quality of life - Month 1 - OHIP-14 (Oral Health Impact Profile-14)
Time frame: 1 month postoperatively
health-related quality of life - Month 3 WHOQOL-BREF (World Health Organization Quality of Life )
Time frame: 3 months postoperatively
health-related quality of life - Month 3 Oral health-related quality OHIP-14 (Oral Health Impact Profile-14)
Time frame: 3 months postoperatively
health-related quality of life - Month 6 WHOQOL-BREF (World Health Organization Quality of Life )
Time frame: 6 months postoperatively
health-related quality of life - Month 6 - OHIP-14 (Oral Health Impact Profile-14)
Time frame: 6 months postoperatively
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 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for 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)
RecruitingPhase 2
The PENTO Protocol in 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.
Claire VILLEPINTE, MD principal investigator
University Hospital, Toulouse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with the use of L-PRF and Standard surgery in people with Osteonecrosis of the Jaw, run by University Hospital, Toulouse at 7 sites in France.
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 3 inclusion and 5 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
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 Franck DELANOË, MD (+33 5 61 77 74 76, delanoe.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of the use of L-PRF (platelet-rich fibrin)during the surgical treatment of Medication-Related Osteonecrosis of the Jaw, compared to surgical treatment alone, on complete mucosal healing. (time frame: 6 months postoperatively). 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 Oct 2026.