Validation of the O-bridge Protocol for Oral Cavity Reconstruction
Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial
This study is testing a new method to help people who have had surgery for tumors in their mouth regain better function and appearance by using a special protocol for jaw reconstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 5 sites (Antwerp and 4 other locations) |
| Trial ID | NCT04007783 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed diagnoses of osteonecrosis or tumors in the oral cavity who require jaw resection and are eligible for fixed prosthetic rehabilitation.
Not a fit: Patients with osteonecrosis unrelated to oncological treatment or those with medical contraindications for jaw reconstruction will not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could enhance the quality of life for patients undergoing oral cavity reconstruction by providing quicker and more effective rehabilitation.
How similar studies have performed: While the O-bridge protocol is a novel approach, similar studies have shown promise in improving outcomes for patients undergoing oral cavity reconstruction.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Antwerp and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.