Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw (PeRFOrMand)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Osteonecrosis of the Jaw

Treatments: Procedure: Standard surgery; Procedure: Surgery with the use of L-PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT06419010

RC31/21/0165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Experimental group

Experimental group

Description:

Patients will benefit from surgery with the use of L-PRF.

Treatment:

Procedure: Surgery with the use of L-PRF

Control group

Other group

Description:

Patients will benefit from standard surgical treatment.

Treatment:

Procedure: Standard surgery