Vascularized Free Fibula Flap and Computer-guided Implant Surgery

Long-term Results of Mandibular/Maxillary Reconstruction With Vascularized Free Fibula Flap and Computer-guided Implant Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Oral Tumor

• Study Type: Observational
• Enrollment (Anticipated): 5

Contacts and Locations

Study Locations

• Italy
  • Bari
    • Acquaviva Delle Fonti, Bari, Italy, 70021
      • Recruiting
      • Ospedale regionale F. Miulli
      • Contact: ROBERTO CORTELAZZI; Phone Number: 080 +39 803054566; Email: robertocortelazzi@hotmail.com
      • Principal Investigator: MICHELE DE BENEDITTIS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with free fibula flaps for maxillary and mandibular reconstruction

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
pain	12 months and 24 months
peri-implant infection	12 months and 24 months

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Principal Investigator: MICHELE DE BENEDITTIS, RESEARCHER, University of Bari

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 23, 2012

Study Record Updates

• Last Update Posted (Estimate): March 23, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: fibula flap; oral implants; computer-guided
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Mouth Neoplasms
• Other Study ID Numbers: 0104 (CCOP)