Vascularized Free Fibula Flap and Computer-guided Implant Surgery
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Purpose
The rehabilitation of patients affected by defects of the jaws after tumor resection is still very challenging. Resection can lead to significant facial deformity, impaired oral functions such as speech, swallowing, saliva retention, and concomitant psychological problems. Moreover, the loss of teeth and the alveolar and basal jawbone can lead to significant impairment of mastication. The reconstruction of such defects with autogenous bone grafts or revascularized free flaps has become a valuable means for the rehabilitation of these patients. Major benefits of such procedure include an usually low morbidity of the donor site and an extensive length of the bone graft. Moreover, vascularized grafts provide a good bulk of bone in which to place implants and a satisfactory contour. In fact, after reconstruction, local hard and soft tissue conditions often exclude the integration of conventional dentures because of the impairment of dental prosthetic retention by thin cutaneous tissue, the thickness of subcutaneous tissues, the absence of a perilingual and vestibular groove, and the fragility of soft tissues. In Literature it has been well established the high biologic value of vascularized fibula grafts regarding the potential of implant osseointegration, which seemed to be equal to regional mandibular or maxillary bone and eventually capable to provide sufficient stabilization of prosthesis.
It must be kept in mind that the final prosthetic success may be affected by some difficulties in this clinical scenario. These include the limited opening of the scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little information about the profile of the underlying harvested bone, the need for limited bony exposure in a field that may well have been irradiated and they all may cause poor prosthetically-guided implant positioning and eventually disappointing results in dental rehabilitation, either functionally or esthetically. It can be postulated that these complications can be overcome, or at least reduced, by adopting the new methods of computed tomography (CT)-assisted implant surgery.
| Condition |
|---|
|
Oral Tumor |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-term Results of Mandibular/Maxillary Reconstruction With Vascularized Free Fibula Flap and Computer-guided Implant Surgery |
- change of peri-implant bone level from baseline at 12 and 24 months [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
successful implants will be those with peri-implant bone resorption less than 1.5 mm in the first year of function and less than
0.2 mm in the subsequent years
- pain [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
- peri-implant infection [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with free fibula flaps for maxillary and mandibular reconstruction
Inclusion Criteria:
- patients with free fibula flaps for maxillary and mandibular reconstruction needing full arch or quasi full arch rehabilitation
Exclusion Criteria:
- radiation therapy
- malignant tumor
Contacts and Locations| Italy | |
| Ospedale regionale F. Miulli | Recruiting |
| Acquaviva Delle Fonti, Bari, Italy, 70021 | |
| Contact: ROBERTO CORTELAZZI +39 803054566 ext 080 robertocortelazzi@hotmail.com | |
| Principal Investigator: MICHELE DE BENEDITTIS | |
| Principal Investigator: | MICHELE DE BENEDITTIS, RESEARCHER | University of Bari |
More Information
No publications provided
| Responsible Party: | MICHELE DE BENEDITTIS, principal investigator, University of Bari |
| ClinicalTrials.gov Identifier: | NCT01561534 History of Changes |
| Other Study ID Numbers: | 0104 |
| Study First Received: | March 13, 2012 |
| Last Updated: | March 21, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Bari:
|
fibula flap oral implants computer-guided |
Additional relevant MeSH terms:
|
Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013