An interventional study of Surgery with the use of L-PRF and Standard surgery in Osteonecrosis of the Jaw, sponsored by University Hospital, Toulouse. Not yet recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment
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.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 150 is above the median of 68 across 151 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will benefit from surgery with the use of L-PRF.
Procedure: Surgery with the use of L-PRF
Patients will benefit from standard surgical treatment.
Procedure: Standard surgery
The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes
The standard surgical treatment, taking place in the operating room under general anesthesia
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.
Time frame: 6 months postoperatively
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 6 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Toulouse →