Clinical trial NCT06419010: Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Official title: Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteonecrosis of the Jaw
Keywords: therapeutics
surgical
autologous platelet concentrates
Platelet-Rich Fibrin
PRF
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing.
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: MRONJ stage - Month 1
timeFrame: 1 month postoperatively
measure: MRONJ stage - Month 3
timeFrame: 3 months postoperatively
measure: MRONJ stage - Month 6
timeFrame: 6 months postoperatively
measure: the postoperative pain - Month 1
timeFrame: 1 month postoperatively
measure: the postoperative pain - Month 3
timeFrame: 3 months postoperatively
measure: the postoperative pain - Month 6
timeFrame: 6 months postoperatively
measure: health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF
timeFrame: 1 month postoperatively
measure: health-related quality of life - Month 1 - OHIP-14
timeFrame: 1 month postoperatively
measure: health-related quality of life - Month 3 WHOQOL-BREF
timeFrame: 3 months postoperatively
measure: health-related quality of life - Month 3 Oral health-related quality OHIP-14
timeFrame: 3 months postoperatively
measure: health-related quality of life - Month 6 WHOQOL-BREF
timeFrame: 6 months postoperatively
measure: health-related quality of life - Month 6 - OHIP-14
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital - Centre François-Xavier Michelet
city: Bordeaux
country: France
facility: University Hospital - Groupe hospitalier Pellegrin
city: Limoges
country: France
facility: University Hospital
city: Montpellier
country: France
facility: University Hospital Gui de CHAULIAC
city: Paris
country: France
facility: University Hospital Pitié-Salpêtrière
city: Toulouse
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Claire VILLEPINTE, MD
role: PRINCIPAL_INVESTIGATOR
References: