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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
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
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
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.
Time frame: 6 months postoperatively
MRONJ stage - Month 1
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
Time frame: 1 month postoperatively
MRONJ stage - Month 3
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
Time frame: 3 months postoperatively
MRONJ stage - Month 6
Evaluation and comparison between the 2 groups of the evolution of the MRONJ 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
Time frame: 1 month postoperatively
health-related quality of life - Month 1 - OHIP-14
oral health-related quality of life will be assessed via the OHIP-14 questionnaire.
Time frame: 1 month postoperatively
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.
Time frame: 3 months postoperatively
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.
Time frame: 3 months postoperatively
health-related quality of life - Month 6 WHOQOL-BREF
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-related quality of life will be assessed via the OHIP-14 questionnaire.
Time frame: 6 months postoperatively
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