This trial is active, not recruiting.

Conditions mandible, osteoradionecrosis
Treatment hybrid bone substitution
Sponsor Nantes University Hospital
Start date November 2009
End date February 2017
Trial size 10 participants
Trial identifier NCT01147315, 08/10-H


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
hybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis

Primary Outcomes

The cure of ORN
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adult patients (between 18 and 75 years) affiliated with an appropriate social security system, diagnosed as suffering from symptomatic ORN, radiologically confirmed, for which surgery is indicated - Presence maximum of 2 outbreaks of ORN - Oncological remission of the original tumor site for 1 year and for 3 years if the ORN is in the contact or close to the initial tumoral site - ECOG performance status 0, 1 or 2 - ORN symptomatic accessible to the conservation of at least one cortical mandibular basilar - Signed informed consent Exclusion Criteria: - Oncological treatment - Haematologic background - Current bone necrosis consecutive or concurrent to taking bisphosphonates - Extension of ORN does not allow the retention of a mandibular rod (bicortical form) - Presence of fracture complicating ORN - Bisphosphonates during the last year - Contraindications to the removal of iliac or sternum bone marrow - Contraindication for general anesthesia

Additional Information

Official title 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment
Principal investigator Olivier Malard, Pr
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Nantes University Hospital.