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

NCT ID: NCT06419010

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-05-31

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.

Conditions

Osteonecrosis of the Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Surgery with the use of L-PRF

Intervention Type: PROCEDURE

The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes

Control group

Patients will benefit from standard surgical treatment.

Group Type: OTHER

Standard surgery

Intervention Type: PROCEDURE

The standard surgical treatment, taking place in the operating room under general anesthesia

Interventions

Surgery with the use of L-PRF

The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes

Intervention Type: PROCEDURE

Standard surgery

The standard surgical treatment, taking place in the operating room under general anesthesia

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire VILLEPINTE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital - Centre François-Xavier Michelet

Bordeaux, , France

University Hospital - Groupe hospitalier Pellegrin

Bordeaux, , France

University Hospital

Limoges, , France

University Hospital Gui de CHAULIAC

Montpellier, , France

University Hospital Pitié-Salpêtrière

Paris, , France

University Hospital

Toulouse, , France

University Hospital

Toulouse, , France

Countries

France

Central Contacts

Franck DELANOË, MD

Role: CONTACT

delanoe.f@chu-toulouse.fr

+33 5 61 77 74 76

Facility Contacts

Mathieu BONDAZ, MD

Role: primary

mathieu.bondaz@chu-bordeaux.fr

05 56 79 56 79 ext. +33

Jean-Christophe FRICAIN, MD

Role: primary

jean-christophe.fricain@u-bordeaux.fr

05 56 79 56 79 ext. +33

Julie USSEGLIO, MD

Role: primary

julie.usseglio@chu-limoges.fr

05 55 05 61 20 ext. +33

Marie DE BOUTRAY, MD

Role: primary

m-deboutray@chu-montpellier.fr

04 67 33 68 03 ext. +33

Géraldine LESCAILLE, MD

Role: primary

01 42 17 84 16 ext. +33

Franck DELANOE, MD

Role: primary

delanoe.f@chu-toulouse.fr

05 61 77 74 76 ext. +33

Clément CAMBRONNE, MD

Role: primary

cambronne.c@chu-toulouse.fr

06 78 18 54 78 ext. +33

Other Identifiers

RC31/21/0165

Identifier Type: -

Identifier Source: org_study_id