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Vascularized Free Fibula Flap and Computer-guided Implant Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by MICHELE DE BENEDITTIS, University of Bari.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
MICHELE DE BENEDITTIS, University of Bari Identifier:
First received: March 13, 2012
Last updated: March 21, 2012
Last verified: March 2012

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.

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

Resource links provided by NLM:

Further study details as provided by MICHELE DE BENEDITTIS, University of Bari:

Primary Outcome Measures:
  • change of peri-implant bone level from baseline at 12 and 24 months [ Time Frame: 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:
  • pain [ Time Frame: 12 months and 24 months ]
  • peri-implant infection [ Time Frame: 12 months and 24 months ]

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)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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Please refer to this study by its identifier: NCT01561534

Ospedale regionale F. Miulli Recruiting
Acquaviva Delle Fonti, Bari, Italy, 70021
Contact: ROBERTO CORTELAZZI    +39 803054566 ext 080   
Principal Investigator: MICHELE DE BENEDITTIS         
Sponsors and Collaborators
University of Bari
Principal Investigator: MICHELE DE BENEDITTIS, RESEARCHER University of Bari
  More Information

Responsible Party: MICHELE DE BENEDITTIS, principal investigator, University of Bari Identifier: NCT01561534     History of Changes
Other Study ID Numbers: 0104
Study First Received: March 13, 2012
Last Updated: March 21, 2012

Keywords provided by MICHELE DE BENEDITTIS, University of Bari:
fibula flap
oral implants
computer-guided processed this record on September 25, 2017