Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
- Conditions
- Upper Digestive Tract Cancer
- Registration Number
- NCT00925509
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
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.
- Detailed Description
* Investigate the accuracy of inserting implants in the vertical way and in angulation, on irradiated native mandible or on microanastomosed fibula flaps
* Investigate the accuracy of inserting implants in the anteroposterior way, in the vertical way and in angulation for all the involved patients (meaning on irradiated native mandible or on microanastomosed fibula flaps)
* Investigate the delay of mucous healing
* Estimate the prosthetic function
* Evaluate the osteonecrosis rate after radiation with traumatic etiology due to implantation
* Estimate the implant rate due to minimally invasive flaps
* Estimate the implant rate due to pure trans mucosa way
* Estimate the post surgical therapeutic success after 1 year
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 53
- age over 18
- Performance status over 70
- Histological evidence of upper digestive tract cancer
- History of cranial / facial radiotherapy or brachytherapy and/or microvascular fibula transfer.
- Bone volume sufficient to support an implant.
- Mandatory affiliation with a social security system
- Written, voluntary, informed consent
- Patient with evolutive malignant disease
- Contraindication to general anesthesia
- Concurrent disease contra-indicating implant surgery (risk of infectious endocarditis, uncontrolled diabetes, HIV, evolutive neoplasia...)
- Patient enrolled in another clinical trial including chemotherapy
- Pregnant or lactating woman
- Anticipation of an impossible follow-up
- Patient deprived of freedom
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Accuracy of implants insertion, radio-surgical guidance. 8 months after inclusion
- Secondary Outcome Measures
Name Time Method Accuracy of inserting implants 16 months after inclusion Delay of mucous healing 16 months after inclusion Estimation of the prosthetic function 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
Trial Locations
- Locations (4)
Hospices Civils de Lyon Service de Consultations et Traitements Dentaires
🇫🇷Lyon, France
Centre Léon Bérard Service de Chirurgie-Stomatologie
🇫🇷Lyon, Cedex 08, France
CHU Hôtel-Dieu Service d'Odontologie
🇫🇷Clermont-ferrand, France
Centre Hospitalier Lyon Sud Service de Stomatologie et Chirurgie Maxillo-Faciale
🇫🇷Pierre Benite, France