Customized Oral and Maxillofacial Reconstruction

NCT ID: NCT04884126

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1996-01-01
• Study Completion Date: 2021-12-01

Brief 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.

Conditions

Prosthesis Failure, Dental; Dental Implant Failed

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

One stage dental implants placement

dental implant placement

Intervention Type: PROCEDURE

The time of dental implant surgery

Second stage dental implants placement

dental implant placement

Intervention Type: PROCEDURE

The time of dental implant surgery

Interventions

dental implant placement

The time of dental implant surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Patients with grafted bone (fibula, iliac, scapula) and receive postoperative implant surgery.

2.Clinical and radiogram data were available for all treatment periods and follow-up visits (Pre-/post-CBCT and panoramic radiographs).

3.Over twelve months follow-up period after implant placement. 4.Age > 18 years. 5.Fabrication and delivery of prosthesis following implant installation. 6.Treatment with a one-stage/two-stage surgical protocol.

Exclusion Criteria

1. Patients diagnosed with osteoporosis.

2. Lost or missing medical history during follow-up period.

3. Follow-up period of dental implants was less than 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Hongyang Ma

PhD researcher,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

S63615

Identifier Type: -

Identifier Source: org_study_id