Customized Oral and Maxillofacial Reconstruction

NCT04884126 | Completed

• 1 other identifier: S63615
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prosthesis Failure, Dental; Dental Implant Failed

Keywords

Dental Implants; Mandibular Reconstruction; Mouth Rehabilitation

Outcome Measures

Primary Outcomes (1)

• The survival rate of the dental implants

  12 months after surgery

Study Arms (2)

One stage dental implants placement

Procedure: dental implant placement

Second stage dental implants placement

Procedure: dental implant placement

Interventions

dental implant placement PROCEDURE

The time of dental implant surgery

One stage dental implants placement; Second stage dental implants placement

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Patients with grafted bone (fibula, iliac, scapula) and receive postoperative implant surgery.
• Clinical and radiogram data were available for all treatment periods and follow-up visits (Pre-/post-CBCT and panoramic radiographs).
• 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.

You may not qualify if:

• Patients diagnosed with osteoporosis.
• Lost or missing medical history during follow-up period.
• Follow-up period of dental implants was less than 12 months.

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD researcher,

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: January 1, 1996
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11