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

Osteonecrosis of the Jaw Clinical Trial

— PeRFOrMand  

Official title:

Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419010
• Other study ID #: RC31/21/0165
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Toulouse
• Contact: Franck DELANOË, MD
• Phone: +33 5 61 77 74 76
• Email: delanoe.f[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Jaw

Intervention

Procedure:
• 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
• Standard surgery
The standard surgical treatment, taking place in the operating room under general anesthesia

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.	6 months postoperatively
Secondary	MRONJ stage - Month 1	Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).	1 month postoperatively
Secondary	MRONJ stage - Month 3	Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).	3 months postoperatively
Secondary	MRONJ stage - Month 6	Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).	6 months postoperatively
Secondary	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).	1 month postoperatively
Secondary	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).	3 months postoperatively
Secondary	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).	6 months postoperatively
Secondary	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	1 month postoperatively
Secondary	health-related quality of life - Month 1 - OHIP-14	oral health-related quality of life will be assessed via the OHIP-14 questionnaire.	1 month postoperatively
Secondary	health-related quality of life - Month 3 WHOQOL-BREF	Overall quality of life will be assessed by the WHOQOL-BREF questionnaire and oral health-related quality of life will be assessed via the OHIP-14 questionnaire.	3 months postoperatively
Secondary	health-related quality of life - Month 3 Oral health-related quality OHIP-14	Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 questionnaire.	3 months postoperatively
Secondary	health-related quality of life - Month 6 WHOQOL-BREF	Overall quality of life will be assessed by the WHOQOL-BREF questionnaire	6 months postoperatively
Secondary	health-related quality of life - Month 6 - OHIP-14	Oral health-related quality of life will be assessed via the OHIP-14 questionnaire.	6 months postoperatively