An interventional study of Hybrid bone substitution in Mandible and Osteoradionecrosis, sponsored by Nantes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
24 studies on the registry are indexed under Osteoradionecrosis; 8 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 13 interventional studies indexed under Osteoradionecrosis.
Browse Osteoradionecrosis studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow
Procedure: Hybrid bone substitution
The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
The cure of ORN
Time frame: 12 months
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
The record gives a start of Nov 2009, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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