NCT06419010

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
May 2024May 2027

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

April 29, 2024

Last Update Submit

May 16, 2024

Conditions

Osteonecrosis of the Jaw

Keywords

therapeuticssurgicalautologous platelet concentratesPlatelet-Rich FibrinPRF

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months postoperatively

Secondary Outcomes (12)

  • MRONJ stage - Month 1

    1 month postoperatively

  • MRONJ stage - Month 3

    3 months postoperatively

  • MRONJ stage - Month 6

    6 months postoperatively

  • the postoperative pain - Month 1

    1 month postoperatively

  • the postoperative pain - Month 3

    3 months postoperatively

  • +7 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Procedure: Surgery with the use of L-PRF

Control group

OTHER

Patients will benefit from standard surgical treatment.

Procedure: Standard surgery

Interventions

Surgery with the use of L-PRFPROCEDURE

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

Experimental group
Standard surgeryPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital - Centre François-Xavier Michelet

Bordeaux, France

Location

University Hospital - Groupe hospitalier Pellegrin

Bordeaux, France

Location

University Hospital

Limoges, France

Location

University Hospital Gui de CHAULIAC

Montpellier, France

Location

University Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

University Hospital

Toulouse, 31000, France

Location

University Hospital

Toulouse, France

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Claire VILLEPINTE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franck DELANOË, MD

CONTACT

+33 5 61 77 74 76delanoe.f@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 17, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)