Clinical Trial: ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis

Brief Summary: The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: The cure of ORN [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of post operative pain at mandibular and bone marrow sampling site
  • Quality of life
  • Possibility of secondary dental prosthetic devices
  • CT semiology description of the treated area
  • Bone regeneration
    Bone regeneration: kinetics of formation of new bone and biomaterial resorption
  • Number of hospital days
  • Safety of hybrid bone substitution


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: June 17, 2010
Date Started: November 18, 2009
Date Completion:
Last Updated: May 22, 2017
Last Verified: May 2017