Clinical trial · Interventional
Application of Medical Imaging Procedures in Surgery Implanting in Cancerology With the Aim to Reduce Invasive Acts
NCT00925509CI-TRIAL-00005055ATIMterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment, too much selective inclusion criteria, feasibility problems
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Upper Digestive Tract Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic assessment -Radio-surgical guidance. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accuracy of implants insertion, radio-surgical guidance.
- timeFrame
- 8 months after inclusion
Secondary outcomes (6)
- measure
- Accuracy of inserting implants
- timeFrame
- 16 months after inclusion
- measure
- Delay of mucous healing
- timeFrame
- 16 months after inclusion
- measure
- Estimation of the prosthetic function
- timeFrame
- 16 months after inclusion
- measure
- Osteonecrosis rate after radiation with traumatic etiology due to implantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (38)
- BACKGROUNDBeumer J 3rd, Roumanas E, Nishimura R. Advances in osseointegrated implants for dental and facial rehabilitation following major head and neck surgery. Semin Surg Oncol. 1995 May-Jun;11(3):200-7. doi: 10.1002/ssu.2980110305. PMID 7638507
- BACKGROUNDBirkfellner W, Solar P, Gahleitner A, Huber K, Kainberger F, Kettenbach J, Homolka P, Diemling M, Watzek G, Bergmann H. In-vitro assessment of a registration protocol for image guided implant dentistry. Clin Oral Implants Res. 2001 Feb;12(1):69-78. doi: 10.1034/j.1600-0501.2001.012001069.x. PMID 11168273
- BACKGROUNDBrosky ME, Korioth TW, Hodges J. The anterior cantilever in the implant-supported screw-retained mandibular prosthesis. J Prosthet Dent. 2003 Mar;89(3):244-9. doi: 10.1067/mpr.2003.43. PMID 12644798
- BACKGROUNDCasap N, Wexler A, Persky N, Schneider A, Lustmann J. Navigation surgery for dental implants: assessment of accuracy of the image guided implantology system. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):116-9. doi: 10.1016/j.joms.2004.06.028. PMID 15332188
- BACKGROUNDCasap N, Wexler A, Tarazi E. Application of a surgical navigation system for implant surgery in a deficient alveolar ridge postexcision of an odontogenic myxoma. J Oral Maxillofac Surg. 2005 Jul;63(7):982-8. doi: 10.1016/j.joms.2005.03.015. PMID 16003627
- BACKGROUNDDelannes M, Daly NJ, Bonnet J, Sabatier J, Tremoulet M. Fractionated radiotherapy of small inoperable lesions of the brain using a non-invasive stereotactic frame. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):749-55. doi: 10.1016/0360-3016(91)90695-z. PMID 1869468
- BACKGROUNDEsser E, Wagner W. Dental implants following radical oral cancer surgery and adjuvant radiotherapy. Int J Oral Maxillofac Implants. 1997 Jul-Aug;12(4):552-7.