Registry for Prosthodontic Rehabilitation in Cancer Patients Undergoing Jaw Reconstruction
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
This study is trying to gather information from cancer patients who are getting jaw reconstruction to see how different factors affect their dental treatment and overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT02661139 on ClinicalTrials.gov |
What this trial studies
This study aims to create a prospective database to collect patient demographics, surgical, dental, prosthetic, and quality of life (QOL) parameters for oncology patients undergoing jaw reconstruction. It focuses on patients with head and neck cancer, osteoradionecrosis, or medication-related osteonecrosis of the jaw who are eligible for fixed prosthodontic rehabilitation. The study will track these parameters during routine visits to better understand factors influencing the stability and success of prosthetic rehabilitation. The collaboration between oral and maxillofacial surgeons and prosthodontists aims to improve patient outcomes through a streamlined rehabilitation protocol.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages and genders with confirmed diagnoses of osteoradionecrosis, medication-related osteonecrosis of the jaw, or oral cavity carcinoma requiring jaw resection.
Not a fit: Patients with osteonecrosis unrelated to cancer treatment or those eligible for conventional removable prosthetic rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for patients undergoing jaw reconstruction by providing effective prosthodontic rehabilitation.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients undergoing jaw reconstruction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of all ages * Patients of all genders * Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring 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 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 eligible for conventional removable prosthetic rehabilitation
Where this trial is running
Bruges
- General Hospital Saint-John Bruges — Bruges, Belgium (Recruiting)
Study contacts
- Principal investigator: Johan Abeloos, MD — Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
- Study coordinator: Araceli Diez-Fraile, PhD
- Email: araceli.diez-fraile@azsintjan.be
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.