Status:

UNKNOWN

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

Lead Sponsor:

University of Roma La Sapienza

Collaborating Sponsors:

NYU College of Dentistry

Universidade da Coruña

Conditions:

Osteonecrosis Due to Drugs, Jaw

Eligibility:

All Genders

Phase:

PHASE2

PHASE3

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2022

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT03390777

Start Date

September 1 2018

End Date

January 1 2022

Last Update

January 8 2018

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