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

May 16, 2024 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France
        • University Hospital - Centre François-Xavier Michelet
        • Contact:
        • Principal Investigator:
          • Mathieu BONDAZ, MD
      • Bordeaux, France
        • University Hospital - Groupe hospitalier Pellegrin
        • Contact:
        • Principal Investigator:
          • Jean-Christophe FRICAIN, MD
      • Limoges, France
        • University Hospital
        • Principal Investigator:
          • Julie USSEGLIO, MD
        • Contact:
      • Montpellier, France
        • University Hospital Gui de CHAULIAC
        • Contact:
        • Principal Investigator:
          • Marie DE BOUTRAY, MD
      • Paris, France, 75013
        • University Hospital Pitié-Salpêtrière
        • Contact:
          • Géraldine LESCAILLE, MD
          • Phone Number: +33 01 42 17 84 16
        • Principal Investigator:
          • Géraldine LESCAILLE, MD
      • Toulouse, France, 31000
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Franck DELANOE, MD
      • Toulouse, France
        • University Hospital
        • Contact:
        • Principal Investigator:
          • Clément CAMBRONNE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Patients will benefit from surgery with the use of L-PRF.
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
Other: Control group
Patients will benefit from standard surgical treatment.
Procedure: Standard surgery
The standard surgical treatment, taking place in the operating room under general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRONJ stage - Month 1
Time Frame: 1 month postoperatively
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
1 month postoperatively
MRONJ stage - Month 3
Time Frame: 3 months postoperatively
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
3 months postoperatively
MRONJ stage - Month 6
Time Frame: 6 months postoperatively
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
6 months postoperatively
the postoperative pain - Month 1
Time Frame: 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).
1 month postoperatively
the postoperative pain - Month 3
Time Frame: 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).
3 months postoperatively
the postoperative pain - Month 6
Time Frame: 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).
6 months postoperatively
health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF
Time Frame: 1 month postoperatively
Overall quality of life will be assessed by the WHOQOL-BREF questionnaire
1 month postoperatively
health-related quality of life - Month 1 - OHIP-14
Time Frame: 1 month postoperatively
oral health-related quality of life will be assessed via the OHIP-14 questionnaire.
1 month postoperatively
health-related quality of life - Month 3 WHOQOL-BREF
Time Frame: 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.
3 months postoperatively
health-related quality of life - Month 3 Oral health-related quality OHIP-14
Time Frame: 3 months postoperatively
Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 questionnaire.
3 months postoperatively
health-related quality of life - Month 6 WHOQOL-BREF
Time Frame: 6 months postoperatively
Overall quality of life will be assessed by the WHOQOL-BREF questionnaire
6 months postoperatively
health-related quality of life - Month 6 - OHIP-14
Time Frame: 6 months postoperatively
Oral health-related quality of life will be assessed via the OHIP-14 questionnaire.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claire VILLEPINTE, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/21/0165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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