Vascularized Free Fibula Flap and Computer-guided Implant Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Bari.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
MICHELE DE BENEDITTIS, University of Bari
ClinicalTrials.gov Identifier:
NCT01561534
First received: March 13, 2012
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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
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 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • peri-implant infection [ Time Frame: 12 months and 24 months ] [ Designated as safety issue: No ]

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)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with free fibula flaps for maxillary and mandibular reconstruction

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561534

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

No publications provided

Responsible Party: MICHELE DE BENEDITTIS, principal investigator, University of Bari
ClinicalTrials.gov Identifier: NCT01561534     History of Changes
Other Study ID Numbers: 0104
Study First Received: March 13, 2012
Last Updated: March 21, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bari:
fibula flap
oral implants
computer-guided

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 28, 2014