Validation of the O-bridge Protocol for Oral Cavity Reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the O-bridge protocol, which aims to improve oral function and aesthetics after major surgery for benign or malignant tumors in the oral cavity. It is a prospective, observational cohort study involving at least 20 patients who require jaw reconstruction and are eligible for immediate or delayed fixed prosthetic rehabilitation. The protocol combines implant loading with a specialized prosthetic manufacturing process to reduce treatment time significantly. Patients will be assessed for clinical function and speech intelligibility before and after surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ziekenhuis Netwerk Antwerpen
  Antwerp, Belgium Recruiting
• ZMACK association - Antwerp University Hospital
  Antwerp, Belgium Recruiting
• Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
  Bruges, Belgium Recruiting
• University Hospital Leuven
  Leuven, Belgium Recruiting
• AZ Nikolaas
  Sint-Niklaas, Belgium Recruiting

Study contacts

• Principal investigator: Johan Abeloos, MD — AZ Sint-Lucas Brugge
• Study coordinator: Araceli Diez-Fraile, PhD
• Email: araceli.diez-fraile@azsintjan.be
• Phone: 0032(0)50459660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.