Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Head and Neck Cancer Clinical Trial

— O-BRIDGE  

Official title:

Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02661139
• Other study ID #: B049201525496
• Status: Recruiting
• Start date: June 2013
• Est. completion date: December 2027

Study information

• Verified date: February 2022
• Source: AZ Sint-Jan AV
• Contact: Araceli Diez-Fraile, PhD
• Email: araceli.diez-fraile[@]azsintjan.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2027
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Osteonecrosis
• Osteoradionecrosis

Locations

Country	Name	City	State
Belgium	General Hospital Saint-John Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction, as measured through visual analogue scale		until a maximum of 60 months follow-up
Primary	implant survival rate		within 12 months postoperative
Primary	bone resorption, as evaluated with cone-beam computed tomography		within 12 months postoperative
Primary	prosthesis survival rate		within 12 months postoperative
Primary	implant survival rate		within 60 months postoperative
Primary	bone resorption, as evaluated with cone-beam computed tomography		within 60 months postoperative
Primary	prosthesis survival rate		within 60 months postoperative
Secondary	Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ		within 12 months postoperative
Secondary	Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis		within 60 months postoperative
Secondary	Patient' quality of life after prosthetic rehabilitation		until a maximum of 60 months follow-up