O-BRIDGE: Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Sponsor

AZ Sint-Jan AV (Other)

Overall Status

Recruiting

CT.gov ID

NCT02661139

Collaborator

(none)

Enrollment

Location

174

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Osteonecrosis Osteoradionecrosis

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Other Outcome Measures

patient satisfaction, as measured through visual analogue scale [until a maximum of 60 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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