Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Benign or Malignant Tumour of the Oral Cavity, Stage III-IV Osteonecrosis, Mandibular Reconstruction, Fixed Dental Restoration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial
Overview
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.
Primary outcome measures
- EORTC QLQ C30, for measurement of quality of life [Time frame: 6 weeks after O-bridge placement]
- EORTC QLQ H&N35, for measurement of quality of life [Time frame: 6 weeks after O-bridge placement]
- EORTC QLQ C30, for measurement of quality of life [Time frame: 6 months after O-bridge placement]
- EORTC QLQ H&N35, for measurement of quality of life [Time frame: 6 months after O-bridge placement]
- OHIP, for measurement of quality of life [Time frame: 6 weeks after O-bridge placement]
- OHIP, for measurement of quality of life [Time frame: 6 months after O-bridge placement]
Secondary outcome measures (5)
- percentage of patients with marginal bone loss around implants [Time frame: until one year post implantation]
- percentage of patients with marginal bone loss around implants [Time frame: until five years post implantation]
- percentage of patients with mechanical stability problems of the prosthesis [Time frame: until one year post implantation]
- percentage of patients with mechanical stability problems of the prosthesis [Time frame: until five years post implantation]
- percentage of patients with difficulties in speech intelligibility [Time frame: prior to and 6 weeks post O-bridge]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Belgium · 5 centers
- Ziekenhuis Netwerk Antwerpen — Antwerp
- ZMACK association - Antwerp University Hospital — Antwerp
- Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oost — Bruges
- University Hospital Leuven — Leuven
- AZ Nikolaas — Sint-Niklaas
Identifiers
NCT: NCT04007783 · B322201731284