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 regenerationBone 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