Customized Oral and Maxillofacial Reconstruction
Condition: Prosthesis Failure, Dental; Dental Implant Failed
MeSH terms: Prosthesis Failure
Study type: Observational [Patient Registry]

Summary: 
      Regional oral and maxillofacial defects secondary to ablative tissue resection can contribute
      to severe aesthetic and functional loss, which influences patients' regular life and may
      cause psychological problems. Microvascular free flaps are considered the gold standard for
      reconstructing large oral and maxillofacial defects. In the past decade, with the help of
      computer-aided design (CAD)/ computer-aided manufacturing (CAM) customized implants and
      prosthesis (CIP) have led to a significant improvement of the operative accuracy, improve the
      flap survival rate and enhance the patients' quality of life.

      Concerning the increased overall survival rate of the patients, people pay more attention to
      the quality of life and aesthetic appearance which are influenced by the fitness and
      compatibility of the CIP. However, from literature reviews, the evaluation was various to be
      concluded in some certain conditions from pooled studies.
    

Detailed description: 
      The trial will be conducted in compliance with the principles of the Declaration of Helsinki
      (specifying which amendment), the principles of GCP, and all of the applicable regulatory
      requirements. This protocol and related documents will the for review to the Ethics
      Committee. The Investigator and the Participating Site shall treat all information and data
      relating to the Study disclosed to Participating Site and/or Investigator in this Study as
      confidential and shall not disclose such information to any third parties or use such
      information for any purpose other than the performance of the Study. The collection,
      processing, and disclosure of personal data, such as patient health and medical information
      is subject to compliance with applicable personal data protection and the processing of
      personal data (Directive 95/46/EC and Belgian law of December 8, 1992, on the Protection of
      the Privacy in relation to the Processing of Personal Data). The extracted data will be
      encoded, the subject's EAD-number will be stored separately(site file) from the research data
      and replaced with a unique study ID-code to create a new identity for the subject. The file
      containing the patient-specific EAD-numbers will be kept on a secured UZ Leuven servers.
    

Intervention name(s): dental implant placement
Intervention type(s): Procedure
Intervention description(s): The time of dental implant surgery
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The files of patients diagnosed and treated between December 2004 and January 2020 for
        defect of dentition secondary to jaw resection were retrospectively reviewed. The patients
        who underwent dental implant surgery after ablative tumor resection with segmental
        mandibulectomy and vascularized bone flap graft were retrieved from the database.
      
Keywords: Dental Implants; Mandibular Reconstruction; Mouth Rehabilitation