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

Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial

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.

Study Overview

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

Detailed Description

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.

Objective: The investigators aim to demonstrate the added value of the "O-bridge® protocol" in a larger sample size of at least 20 patients eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity (mandibular) reconstruction study design: a prospective, observational cohort study. The "O-bridge® protocol", in which the standardized concept of implant loading and that of oral cavity (mandibular) reconstruction are combined with an adapted prosthetic manufacturing protocol, will be offered to eligible patients requiring ablative surgery because of a benign or malignant tumour of the oral cavity or stage 3-4 osteonecrosis.

All patients will be screened by the local maxillofacial surgeon and the prosthodontist to determine eligibility for the procedure. Imaging will be performed as part of routine surgical preparation. Clinical function, as measured with the 11-item scale by Rogers and intelligibility of speech will be assessed by the speech therapist and/or appointed health care employee prior to surgery, 3 months post-surgery and/or at time of implant placement, and at 6 weeks after placement of the O-bridge®. In addition, EORTC quality of life C30 and HN35 questionnaires will also be completed at those time-points, and at 6 months after placement of the O-bridge®. Speech-, food- and prosthetic fit-related items from the Oral Health Impact Profile (OHIP) questionnaire will be completed at 6 weeks and at 6 months after placement of the O-bridge®. Parameters related to implant and bridge stability and patient satisfaction, measured through a 10-point visual analogue scale, will be assessed at 6, 12, 24, 36, 48 and 60 months at routine follow-up consultation after placement of the O-bridge®.

As a primary endpoint, the investigators aim to demonstrate that the O-bridge® protocol significantly improves short-term patient' quality of life.

Moreover, the investigators aim to demonstrate the validity and reliability of the O-bridge® protocol, based on its short- and long-term biologic implant stability and mechanical stability of the prosthesis. In addition, they aim to measure the impact of the O-bridge® on speech intelligibility.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Araceli Diez-Fraile, PhD; Phone Number: 0032(0)50459660; Email: araceli.diez-fraile@azsintjan.be

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • Ziekenhuis Netwerk Antwerpen
    • Contact: Olivier Lenssen, MD
  • Antwerp, Belgium
    • Recruiting
    • ZMACK association - Antwerp University Hospital
    • Contact: Wouter De Vos, MD
    • Contact: Elke Van de Casteele, MSc, PhD
  • Bruges, Belgium
    • Recruiting
    • Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
    • Contact: Araceli Diez-Fraile, VMD MSc PhD
  • Leuven, Belgium
    • Recruiting
    • University Hospital Leuven
    • Contact: Constantinus Politis, MD, PhD
  • Sint-Niklaas, Belgium
    • Recruiting
    • AZ Nikolaas
    • Contact: Kristof Hendrickx, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients with marginal bone loss around implants	short-term biologic implant stability, measured through OPG imaging	until one year post implantation
percentage of patients with marginal bone loss around implants	long-term biologic implant stability, measured through OPG imaging	until five years post implantation
percentage of patients with mechanical stability problems of the prosthesis	short-term, measured through clinical evaluation	until one year post implantation
percentage of patients with mechanical stability problems of the prosthesis	long-term, measured through clinical evaluation	until five years post implantation
percentage of patients with difficulties in speech intelligibility	impact of the O-bridge on speech intelligiblity, measured through reading of a predefined oronasal text interpreted by the speech and language pathologist	prior to and 6 weeks post O-bridge

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Principal Investigator: Johan Abeloos, MD, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis
• Other Study ID Numbers: B322201731284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No