Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06419010
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-29
Brief Title:
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PeRFOrMand
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 isnt 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 patients 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
The L-PRF Leukocyte- and Platelet-Rich Fibrin is a second-generation APC produced in a strictly autologous way by extemporaneous centrifugation of the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None