Osteonecrosis of the Jaw
Conditions
Keywords
therapeutics, surgical, autologous platelet concentrates, Platelet-Rich Fibrin, PRF
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.
Interventions
PROCEDURESurgery 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
PROCEDUREStandard surgery
The standard surgical treatment, taking place in the operating room under general anesthesia
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months postoperatively | Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the at risk stage of the AAOMS classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the postoperative pain - Month 3 | 3 months postoperatively | 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). |
| MRONJ stage - Month 3 | 3 months postoperatively | Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). |
| MRONJ stage - Month 6 | 6 months postoperatively | Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). |
| the postoperative pain - Month 1 | 1 month postoperatively | 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). |
| the postoperative pain - Month 6 | 6 months postoperatively | 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). |
| MRONJ stage - Month 1 | 1 month postoperatively | Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). |
| health-related quality of life - Month 1 - OHIP-14 | 1 month postoperatively | oral health-related quality of life will be assessed via the OHIP-14 questionnaire. |
| health-related quality of life - Month 3 WHOQOL-BREF | 3 months postoperatively | 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. |
| health-related quality of life - Month 3 Oral health-related quality OHIP-14 | 3 months postoperatively | Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 questionnaire. |
| health-related quality of life - Month 6 WHOQOL-BREF | 6 months postoperatively | Overall quality of life will be assessed by the WHOQOL-BREF questionnaire |
| health-related quality of life - Month 6 - OHIP-14 | 6 months postoperatively | Oral health-related quality of life will be assessed via the OHIP-14 questionnaire. |
| health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF | 1 month postoperatively | Overall quality of life will be assessed by the WHOQOL-BREF questionnaire |
Countries
France
Contacts
Primary ContactFranck DELANOË, MD
Outcome results
None listed