Clinical Trial

Validation of the O-bridge Protocol: a Prospective, Multicenter Trial

Recruiting
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Record status
This record was last updated February 24, 2022 (before its estimated December 2022 completion). Its status may not reflect the trial's current state.
Summary
Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The "Oncological-bridge (O-bridge®)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-07-02; most recent amendment 2022-02-23.
Trial Details
NCT Number NCT04007783
Lead Sponsor AZ Sint-Jan AV
Conditions Benign or Malignant Tumour of the Oral Cavity, Stage III-IV Osteonecrosis, Mandibular Reconstruction, Fixed Dental Restoration, Quality of Life
Enrollment 80 participants
Start Date 2017-03-04
Primary Completion 2022-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2022-02-24