Oral Tumor Clinical Trial
Official title:
Long-term Results of Mandibular/Maxillary Reconstruction With Vascularized Free Fibula Flap and Computer-guided Implant Surgery
| Verified date | March 2012 |
| Source | University of Bari |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 5 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale regionale F. Miulli | Acquaviva Delle Fonti | Bari |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bari |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of peri-implant bone level from baseline at 12 and 24 months | 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 |
12 months and 24 months | No |
| Secondary | pain | 12 months and 24 months | No | |
| Secondary | peri-implant infection | 12 months and 24 months | No |