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| ID | Type | Description | Link |
|---|---|---|---|
| CPP 07/033 [UBET83] |
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Insufficient recruitment, too much selective inclusion criteria, feasibility problems
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| Name | Class |
|---|---|
| French Academic Institution, Financial support: PHRC 2007 | UNKNOWN |
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Aero digestive Cancer patients treated by external head and neck radiotherapy and/or by curie-therapy and/or mandible reconstruction by microanastomosed fibula flaps. The purpose of the study is to Investigate the accuracy of implants insertion in the anteroposterior way, using radiosurgical guidance.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic assessment -Radio-surgical guidance. | Procedure | The first steps of the procedure include the production of a radiosurgical guide and the preparation of a mask in order to allow precise, non invasive repositioning of the guide. Secondarily, the patient undergoes a CT-scan with the mask on and the radiosurgical guide in place. This provisional scan is used for preimplantation evaluation and drilling of the guide hole. Under general anaesthesia, the mask is placed on the patient and the guide is fixed to the mask. A hole is drilled with a burr in the mandible through the hole in the guide. Implants are placed and the guide and mask are removed. A second, post-implantation CT-scan is planned 3 months after implantation. Comparison of pre- and post-implantation CT-scans allows to evaluate the precision of the placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of implants insertion, radio-surgical guidance. | 8 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of inserting implants | 16 months after inclusion | |
| Delay of mucous healing | 16 months after inclusion | |
| Estimation of the prosthetic function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Gaëlle BODARD, MD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard Service de Chirurgie-Stomatologie | Lyon | Cedex 08 | 69373 | France | ||
| CHU Hôtel-Dieu Service d'Odontologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 16 months after inclusion |
| Osteonecrosis rate after radiation with traumatic etiology due to implantation | 16 months after inclusion |
| Implant rate | 16 months after inclusion |
| Post surgical therapeutic success after 1 year | after 1 year |
| Clermont-Ferrand |
| 63 000 |
| France |
| Hospices Civils de Lyon Service de Consultations et Traitements Dentaires | Lyon | 69007 | France |
| Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale | Pierre-Bénite | 69495 | France |
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