Validation of the O-bridge Protocol: a Prospective, Multicenter Trial

NCT04007783 | Recruiting

• 1 other identifier: B322201731284
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The "Oncological-bridge (O-bridge®)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.

Conditions

Benign or Malignant Tumour of the Oral Cavity; Stage III-IV Osteonecrosis; Mandibular Reconstruction; Fixed Dental Restoration; Quality of Life

Outcome Measures

Primary Outcomes (6)

• EORTC QLQ C30, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30 questionnaire

  6 weeks after O-bridge placement

• EORTC QLQ H&N35, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35 questionnaire

  6 weeks after O-bridge placement

• EORTC QLQ C30, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30

  6 months after O-bridge placement

• EORTC QLQ H&N35, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35

  6 months after O-bridge placement

• OHIP, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire

  6 weeks after O-bridge placement

• OHIP, for measurement of quality of life

  short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire

  6 months after O-bridge placement

Secondary Outcomes (5)

• percentage of patients with marginal bone loss around implants

  until one year post implantation

• percentage of patients with marginal bone loss around implants

  until five years post implantation

• percentage of patients with mechanical stability problems of the prosthesis

  until one year post implantation

• percentage of patients with mechanical stability problems of the prosthesis

  until five years post implantation

• percentage of patients with difficulties in speech intelligibility

  prior to and 6 weeks post O-bridge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ORN, MRONJ, benign or malignant tumour in the head and neck region requiring ablative oral cavity resection including marginal, segmental or total bony jaw resection

You may qualify if:

• Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by respectively Lyons et al. (Lyons, et al., 2014) and Ruggiero et al. (Ruggiero, et al., 2009) (Ruggiero, et al., 2014) or a benign or malignant tumour located in the oral cavity and jaw bone (NCCN, 2015) (Sobin, et al., 2009), requiring marginal, 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

You may not qualify if:

• Patients not eligible to the abovementioned 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 whose maternal language is non-Dutch or non-English will be excluded from the acoustic speech evaluation. A perceptual evaluation of speech intelligibility can still be performed.

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (5)

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

RECRUITING

ZMACK association - Antwerp University Hospital

Antwerp, Belgium

RECRUITING

Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

AZ Nikolaas

Sint-Niklaas, Belgium

RECRUITING

Study Officials

• Johan Abeloos, MD

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Araceli Diez-Fraile, PhD

CONTACT

0032(0)50459660; araceli.diez-fraile@azsintjan.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: July 5, 2019
• Study Start: March 4, 2017
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)