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

NCT ID: NCT04007783

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-04
• Study Completion Date: 2027-12-31

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Johan Abeloos

head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Locations

Ziekenhuis Netwerk Antwerpen

Antwerp, , Belgium

Site Status: RECRUITING

ZMACK association - Antwerp University Hospital

Antwerp, , Belgium

Site Status: RECRUITING

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

Bruges, , Belgium

Site Status: RECRUITING

University Hospital Leuven

Leuven, , Belgium

Site Status: RECRUITING

AZ Nikolaas

Sint-Niklaas, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Araceli Diez-Fraile, PhD

Role: CONTACT

araceli.diez-fraile@azsintjan.be

0032(0)50459660

Facility Contacts

Olivier Lenssen, MD

Role: primary

Wouter De Vos, MD

Role: primary

Elke Van de Casteele, MSc, PhD

Role: backup

Araceli Diez-Fraile, VMD MSc PhD

Role: primary

Constantinus Politis, MD, PhD

Role: primary

Kristof Hendrickx, MD

Role: primary

Other Identifiers

B322201731284

Identifier Type: -

Identifier Source: org_study_id