Clinical Trial: Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

Brief Summary:

The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.


Detailed Summary:
Sponsor: AZ Sint-Jan AV

Current Primary Outcome:

  • implant survival rate [ Time Frame: within 12 months postoperative ]
  • bone resorption, as evaluated with cone-beam computed tomography [ Time Frame: within 12 months postoperative ]
  • prosthesis survival rate [ Time Frame: within 12 months postoperative ]
  • implant survival rate [ Time Frame: within 60 months postoperative ]
  • bone resorption, as evaluated with cone-beam computed tomography [ Time Frame: within 60 months postoperative ]
  • prosthesis survival rate [ Time Frame: within 60 months postoperative ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ [ Time Frame: within 12 months postoperative ]
  • Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis [ Time Frame: within 60 months postoperative ]
  • Patient' quality of life after prosthetic rehabilitation [ Time Frame: until a maximum of 60 months follow-up ]


Original Secondary Outcome: Same as current

Information By: AZ Sint-Jan AV

Dates:
Date Received: January 11, 2016
Date Started: June 2013
Date Completion: December 2023
Last Updated: January 19, 2016
Last Verified: January 2016