Vascularized Free Fibula Flap and Computer-guided Implant Surgery

• Conditions: Oral Tumor

• Registration Number: NCT01561534
• Lead Sponsor: University of Bari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Study First Posted: 2012-03-23
• Last Update Posted: 2012-03-23
• Primary Completion: 2013-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of peri-implant bone level from baseline at 12 and 24 months	12 months 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

Secondary Outcome Measures

Name	Time	Method
pain	12 months and 24 months
peri-implant infection	12 months and 24 months

Trial Locations

Locations (1)

Ospedale regionale F. Miulli; 🇮🇹 Acquaviva Delle Fonti, Bari, Italy