Clinical trial NCT04007783: Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
Official title: Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign or Malignant Tumour of the Oral Cavity
Stage III-IV Osteonecrosis
Mandibular Reconstruction
Fixed Dental Restoration
Quality of Life
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: EORTC QLQ C30, for measurement of quality of life
timeFrame: 6 weeks after O-bridge placement
measure: EORTC QLQ H&N35, for measurement of quality of life
timeFrame: 6 weeks after O-bridge placement
measure: EORTC QLQ C30, for measurement of quality of life
timeFrame: 6 months after O-bridge placement
measure: EORTC QLQ H&N35, for measurement of quality of life
timeFrame: 6 months after O-bridge placement
measure: OHIP, for measurement of quality of life
timeFrame: 6 weeks after O-bridge placement
measure: OHIP, for measurement of quality of life
timeFrame: 6 months after O-bridge placement
Secondary outcomes:
measure: percentage of patients with marginal bone loss around implants
timeFrame: until one year post implantation
measure: percentage of patients with marginal bone loss around implants
timeFrame: until five years post implantation
measure: percentage of patients with mechanical stability problems of the prosthesis
timeFrame: until one year post implantation
measure: percentage of patients with mechanical stability problems of the prosthesis
timeFrame: until five years post implantation
measure: percentage of patients with difficulties in speech intelligibility
timeFrame: prior to and 6 weeks post O-bridge
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen
city: Antwerp
country: Belgium
facility: ZMACK association - Antwerp University Hospital
city: Bruges
country: Belgium
facility: Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References: