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

StatusRecruiting
PhaseNot specified
Started
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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.

Record History

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  1. Primary completion date: Jul 2021 to Dec 2022
    • Study completion date: Dec 2026 to Dec 2027
    v3
  2. Primary completion date: Jul 2019 to Jul 2021v2 Show 5 more changesShow less
    • Primary endpoints revised (6)
    • Study completion date: Dec 2024 to Dec 2026
    • Study description expanded, about 377 words
    • Study sites revised (5)
    • Study title shortened, about 9 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04007783
Lead Sponsor AZ Sint-Jan AV
Conditions
(from sponsor)		 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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov