Clinical trial NCT02661139: Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
Official title: Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Osteonecrosis
Osteoradionecrosis
Keywords: bisphosphonates
jaw reconstruction
prosthetic rehabilitation
quality of life
monoclonal antibodies' targeted therapy
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consenting patients with a histologically confirmed oncology diagnosis that requires major ablative surgery of the oral cavity, including segmental or total jaw resection, due to head and neck cancer, ORN or MRONJ

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.

Eligibility criteria: 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

Primary outcomes:
measure: implant survival rate
timeFrame: within 12 months postoperative
measure: bone resorption, as evaluated with cone-beam computed tomography
timeFrame: within 12 months postoperative
measure: prosthesis survival rate
timeFrame: within 12 months postoperative
measure: implant survival rate
timeFrame: within 60 months postoperative
measure: bone resorption, as evaluated with cone-beam computed tomography
timeFrame: within 60 months postoperative
measure: prosthesis survival rate
timeFrame: within 60 months postoperative
Secondary outcomes:
measure: Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ
timeFrame: within 12 months postoperative
measure: Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
timeFrame: within 60 months postoperative
measure: Patient' quality of life after prosthetic rehabilitation
timeFrame: until a maximum of 60 months follow-up
Other outcomes:
measure: patient satisfaction, as measured through visual analogue scale
timeFrame: until a maximum of 60 months follow-up
Locations:
city: Bruges
country: Belgium
facility: General Hospital Saint-John Bruges
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: