Vascularized Free Fibula Flap and Computer-guided Implant Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01561534
Recruitment Status : Unknown
Verified March 2012 by MICHELE DE BENEDITTIS, University of Bari.
Recruitment status was:  Recruiting
First Posted : March 23, 2012
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Oral Tumor

Study Type : Observational
Estimated Enrollment : 5 participants
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
Study Start Date : February 2012
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. pain [ Time Frame: 12 months and 24 months ]
  2. peri-implant infection [ Time Frame: 12 months and 24 months ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: MICHELE DE BENEDITTIS, principal investigator, University of Bari Identifier: NCT01561534     History of Changes
Other Study ID Numbers: 0104
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: March 2012

Keywords provided by MICHELE DE BENEDITTIS, University of Bari:
fibula flap
oral implants