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Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts

Not Applicable
Terminated
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
Inclusion Criteria
  • 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
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Exclusion Criteria
  • 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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Accuracy of implants insertion, radio-surgical guidance.8 months after inclusion
Secondary Outcome Measures
NameTimeMethod
Accuracy of inserting implants16 months after inclusion
Delay of mucous healing16 months after inclusion
Estimation of the prosthetic function16 months after inclusion
Osteonecrosis rate after radiation with traumatic etiology due to implantation16 months after inclusion
Implant rate16 months after inclusion
Post surgical therapeutic success after 1 yearafter 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

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