Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Recruiting

• Conditions: Osteoradionecrosis; Head and Neck Cancer; Osteonecrosis

• Registration Number: NCT02661139
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-28
• Primary Completion: 2022-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patients of all ages
• Patients of all genders
• Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring 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

Exclusion Criteria

• Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
• Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
• Patients eligible for conventional removable prosthetic rehabilitation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prosthesis survival rate	within 60 months postoperative
implant survival rate	within 60 months postoperative
bone resorption, as evaluated with cone-beam computed tomography	within 60 months postoperative

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital Saint-John Bruges; 🇧🇪 Bruges, Belgium