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Fixed teeth after jaw reconstruction in people with mouth tumours or jaw bone damage

Studies the O-bridge protocol for fixed teeth after jaw reconstruction surgery.

Key facts

Who runs it
AZ Sint-Jan AV
Where
Belgium5 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
Status
Recruiting
People taking part
80 people, planned
Started
4 Mar 2017
Expected to end
Dec 2027
Type of study
Observational
Record updated
24 February 2022

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who need part or all of the jaw removed because of jaw bone damage after cancer treatment or a tumour in the mouth. They get jaw rebuilding surgery plus fixed teeth on implants.

Age
18 Years and older
Sex
All
Disease stage
Jaw bone death from radiation (ORN) or from bone drugs (MRONJ), or a benign or malignant tumour in the mouth and jaw bone. It must need marginal, segmental or total jaw removal. Stage III-IV osteonecrosis is listed.
Biomarker or test result
Diagnosis confirmed by tissue test or clinical exam.

Main reasons for not taking part

  • Jaw bone death not linked to cancer or cancer treatment
  • Medical reasons that rule out jaw rebuilding with implants loaded right away for fixed teeth
  • People who can use a usual removable denture cannot join
  • People who cannot have jaw rebuilding with implants for fixed teeth
  • People whose first language is not Dutch or English skip the recorded speech test only

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patients with medical contraindications for jaw reconstruction combined with immediate implant loading for fixed prosthetic rehabilitation
  • Patients not eligible to the abovementioned criteria
  • Patients with a clinically confirmed diagnosis of osteonecrosis not related to an oncological diagnosis or treatment
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial
Plain-language title
Fixed teeth after jaw reconstruction in people with mouth tumours or jaw bone damageGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
24 February 2022