Vascularized Free Fibula Flap and Computer-guided Implant Surgery

This study is currently recruiting participants.
Verified March 2012 by University of Bari
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

March 13, 2012
March 21, 2012
February 2012
March 2013   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01561534 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients with free fibula flaps for maxillary and mandibular reconstruction

Oral Tumor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
March 2014
March 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
Italy
 
NCT01561534
0104
Yes
MICHELE DE BENEDITTIS, University of Bari
University of Bari
Not Provided
Principal Investigator: MICHELE DE BENEDITTIS, RESEARCHER University of Bari
University of Bari
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP