Actively Recruiting
Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
Led by AZ Sint-Jan AV · Updated on 2022-02-24
80
Participants Needed
5
Research Sites
560 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of osteonecrosis of the jaw (ORN or MRONJ) or a benign or malignant tumor in the oral cavity or jaw bone requiring jaw resection
- Patients eligible for jaw and oral cavity reconstruction combined with immediate or delayed implant loading for fixed prosthetic rehabilitation
- Patients not eligible for conventional removable prosthetic rehabilitation
You will not qualify if you...
- Patients not meeting the above inclusion criteria
- Patients with osteonecrosis not related to cancer diagnosis or treatment
- Patients with medical reasons preventing jaw reconstruction with immediate implant loading for fixed prosthetic rehabilitation
- Patients whose primary language is not Dutch or English will be excluded from acoustic speech evaluation, though speech intelligibility can still be assessed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
Actively Recruiting
2
ZMACK association - Antwerp University Hospital
Antwerp, Belgium
Actively Recruiting
3
Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
Actively Recruiting
4
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
5
AZ Nikolaas
Sint-Niklaas, Belgium
Actively Recruiting
Research Team
A
Araceli Diez-Fraile, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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