Clinical trial NCT01561534: Vascularized Free Fibula Flap and Computer-guided Implant Surgery
Official title: Long-term Results of Mandibular/Maxillary Reconstruction With Vascularized Free Fibula Flap and Computer-guided Implant Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Tumor
Keywords: fibula flap
oral implants
computer-guided
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with free fibula flaps for maxillary and mandibular reconstruction

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: change of peri-implant bone level from baseline at 12 and 24 months
timeFrame: 12 months and 24 months
Secondary outcomes:
measure: pain
timeFrame: 12 months and 24 months
measure: peri-implant infection
timeFrame: 12 months and 24 months
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale regionale F. Miulli
state: Bari
Study officials:
affiliation: University of Bari
name: MICHELE DE BENEDITTIS, RESEARCHER
role: PRINCIPAL_INVESTIGATOR
References: