## Protocol Section
### Identification Module
**NCT ID:** NCT06419010

**Acronym:** PeRFOrMand

**Brief Title:** Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw

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

#### Organization Study ID Info
**ID:** RC31/21/0165
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Toulouse

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Osteonecrosis of the Jaw

**Keywords:**

- therapeutics

- surgical

- autologous platelet concentrates

- Platelet-Rich Fibrin

- PRF

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will benefit from surgery with the use of L-PRF.

**Intervention Names:**

- Procedure: Surgery with the use of L-PRF

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients will benefit from standard surgical treatment.

**Intervention Names:**

- Procedure: Standard surgery

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes

**Name:** Surgery with the use of L-PRF

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** The standard surgical treatment, taking place in the operating room under general anesthesia

**Name:** Standard surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.

**Measure:** 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

#### Secondary Outcomes

**Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

**Measure:** MRONJ stage - Month 1

**Time Frame:** 1 month postoperatively

**Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

**Measure:** MRONJ stage - Month 3

**Time Frame:** 3 months postoperatively

**Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).

**Measure:** MRONJ stage - Month 6

**Time Frame:** 6 months postoperatively

**Description:** 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).

**Measure:** the postoperative pain - Month 1

**Time Frame:** 1 month postoperatively

**Description:** 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).

**Measure:** the postoperative pain - Month 3

**Time Frame:** 3 months postoperatively

**Description:** 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).

**Measure:** the postoperative pain - Month 6

**Time Frame:** 6 months postoperatively

**Description:** Overall quality of life will be assessed by the WHOQOL-BREF questionnaire

**Measure:** health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF

**Time Frame:** 1 month postoperatively

**Description:** oral health-related quality of life will be assessed via the OHIP-14 questionnaire.

**Measure:** health-related quality of life - Month 1 - OHIP-14

**Time Frame:** 1 month postoperatively

**Description:** 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.

**Measure:** health-related quality of life - Month 3 WHOQOL-BREF

**Time Frame:** 3 months postoperatively

**Description:** Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 questionnaire.

**Measure:** health-related quality of life - Month 3 Oral health-related quality OHIP-14

**Time Frame:** 3 months postoperatively

**Description:** Overall quality of life will be assessed by the WHOQOL-BREF questionnaire

**Measure:** health-related quality of life - Month 6 WHOQOL-BREF

**Time Frame:** 6 months postoperatively

**Description:** Oral health-related quality of life will be assessed via the OHIP-14 questionnaire.

**Measure:** health-related quality of life - Month 6 - OHIP-14

**Time Frame:** 6 months postoperatively

### Eligibility Module

**Eligibility Criteria:** 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).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** delanoe.f@chu-toulouse.fr

**Name:** Franck DELANOË, MD

**Phone:** +33 5 61 77 74 76

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bordeaux

**Contacts:**

***Contact 1:***

- **Email:** mathieu.bondaz@chu-bordeaux.fr

- **Name:** Mathieu BONDAZ, MD

- **Phone:** 05 56 79 56 79

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mathieu BONDAZ, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital - Centre François-Xavier Michelet

**Location 2:**

**City:** Bordeaux

**Contacts:**

***Contact 1:***

- **Email:** jean-christophe.fricain@u-bordeaux.fr

- **Name:** Jean-Christophe FRICAIN, MD

- **Phone:** 05 56 79 56 79

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jean-Christophe FRICAIN, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital - Groupe hospitalier Pellegrin

**Location 3:**

**City:** Limoges

**Contacts:**

***Contact 1:***

- **Email:** julie.usseglio@chu-limoges.fr

- **Name:** Julie USSEGLIO, MD

- **Phone:** 05 55 05 61 20

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Julie USSEGLIO, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital

**Location 4:**

**City:** Montpellier

**Contacts:**

***Contact 1:***

- **Email:** m-deboutray@chu-montpellier.fr

- **Name:** Marie DE BOUTRAY, MD

- **Phone:** 04 67 33 68 03

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marie DE BOUTRAY, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital Gui de CHAULIAC

**Location 5:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Name:** Géraldine LESCAILLE, MD

- **Phone:** 01 42 17 84 16

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Géraldine LESCAILLE, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital Pitié-Salpêtrière

**Zip:** 75013

**Location 6:**

**City:** Toulouse

**Contacts:**

***Contact 1:***

- **Email:** delanoe.f@chu-toulouse.fr

- **Name:** Franck DELANOE, MD

- **Phone:** 05 61 77 74 76

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Franck DELANOE, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital

**Zip:** 31000

**Location 7:**

**City:** Toulouse

**Contacts:**

***Contact 1:***

- **Email:** cambronne.c@chu-toulouse.fr

- **Name:** Clément CAMBRONNE, MD

- **Phone:** 06 78 18 54 78

- **Phone Ext:** +33

- **Role:** CONTACT

***Contact 2:***

- **Name:** Clément CAMBRONNE, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Toulouse

**Name:** Claire VILLEPINTE, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009336

- Term: Necrosis

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12943

- Name: Osteonecrosis

- Relevance: HIGH

- As Found: Osteonecrosis

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010020

- Term: Osteonecrosis

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M6263

- Name: Coal Tar

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
