Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw

Overview

Medication related Osteonecrosis of the Jaw (MRONJ) consists of progressive destruction of bone in the maxillofacial area. It is an established complication which occurs in patients who take two main classes of antiresorptive drugs: Bisphosphonates (BP) and Denosumab.

PRGF is a autologous platelet-enriched plasma obtained from the patient's own blood. It contains proteins that can influence and promote cell recruitment and its beneficial effect could consist in improving bone and soft tissue healing. These benefits are likely to apply to MRONJ surgery, as it is suggested by small retrospective or prospective case series.

This is a randomized, multi center study comparing the outcomes of surgery alone and PRGF plus surgery in patients requiring surgical treatment for MRONJ.

To assess the superiority of surgery plus PRGF compared to surgery alone in patients treated for MRONJ. Primary endpoint for this scope is a composite of clinical or radiological recurrence rate of disease during a 12 months post-operative period.

Secondary endpoints are: a) morbidity, defined as nerve injury, bleeding, vascular or wound complications. b) post- and peri-operative pain defined by the treated subjects according to a standardized VAS score c) quality of life (QoL) defined by a standardized scale.

Full Title of Study: “Plasma Rich in Growth Factors for Treatment of Medication Related Osteonecrosis of the Jaw: a Multicenter, Randomized, Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2021

Interventions

  • Procedure: surgery
    • surgery without the use of prgf
  • Device: PRGF after surgery
    • surgery and application of PRGF

Arms, Groups and Cohorts

  • Active Comparator: surgery only
    • Surgery consisting in debridement/removal of affected tissue/s will be performed.
  • Active Comparator: surgery and PRGF
    • Surgery consisting in debridement/removal of affected tissue/s will be performed. Platelet Rich Growth Factor (device) will be produced by a venous blood sampling of the patient and applied to the treated area

Clinical Trial Outcome Measures

Primary Measures

  • recurrence of disease
    • Time Frame: 12 months
    • clinical or radiological recurrence rate of disease during a 12 months post-operative period

Secondary Measures

  • morbidity
    • Time Frame: 12 months
    • nerve injury, bleeding, vascular or wound complications
  • post- and peri-operative pain
    • Time Frame: 1 week
    • defined by the treated subjects according to a standardized Visual Analog Scale (VAS) score which will be used to define the pain in this way: the patient will assign a value to the experienced pain that goes from 0 no pain to 10 the worst pain the patient can imagine.
  • quality of life (QoL)
    • Time Frame: 12 months
    • defined by a standardized scale developed by the who and whose details can be on the who website http://www.who.int/mental_health/publications/whoqol/en/

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects must be candidates for surgical treatment for MRONJ at stage 2 or 3.
  • Subjects must be >18 and <80 years of age
  • Subjects must sign a informed consent prior to randomization and must agree to return to scheduled follow-up visits

Exclusion Criteria

  • Subject has inability to understand and cooperate with the study procedures or provide informed consent
  • Subject has bleeding diathesis or coaugolapthy, or will refuse autologous blood sampling
  • Subject had a cardiovascular event in the past 30 days
  • Subject has any condition that limits their anticipated survival to less than 3 months

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Roma La Sapienza
  • Collaborator
    • NYU College of Dentistry
  • Provider of Information About this Clinical Study
    • Principal Investigator: Oreste Iocca, DDS, MD – University of Roma La Sapienza
  • Overall Contact(s)
    • Oreste Iocca, D.D.S., M.D., 0039 3398540122, oi243@nyu.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.