Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by respectively Lyons et al. (Lyons, et al., 2014) and Ruggiero et al. (Ruggiero, et al., 2009) (Ruggiero, et al., 2014) or a benign or malignant tumour located in the oral cavity and jaw bone (NCCN, 2015) (Sobin, et al., 2009), requiring marginal, segmental or total jaw resection

• Patients eligible for jaw and oral cavity reconstruction combined with immediate/delayed implant loading for fixed prosthetic rehabilitation

• Patients not eligible for conventional removable prosthetic rehabilitation

Locations
Other Locations
Belgium
Ziekenhuis Netwerk Antwerpen
RECRUITING
Antwerp
ZMACK association - Antwerp University Hospital
RECRUITING
Antwerp
Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
RECRUITING
Bruges
University Hospital Leuven
RECRUITING
Leuven
AZ Nikolaas
RECRUITING
Sint-niklaas
Contact Information
Primary
Araceli Diez-Fraile, PhD
araceli.diez-fraile@azsintjan.be
0032(0)50459660
Time Frame
Start Date: 2017-03-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Related Therapeutic Areas
Sponsors
Leads: AZ Sint-Jan AV

This content was sourced from clinicaltrials.gov