|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 March 2022 |
|
Main ID: |
NCT02661139 |
|
Date of registration:
|
11/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
O-BRIDGE |
|
Scientific title:
|
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction |
|
Date of first enrolment:
|
June 2013 |
|
Target sample size:
|
55 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02661139 |
|
Study type:
|
Observational [Patient Registry] |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Johan Abeloos, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium |
|
|
Name:
|
Araceli Diez-Fraile, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
araceli.diez-fraile@azsintjan.be |
|
Affiliation:
|
|
|
|
Name:
|
Araceli Diez-Fraile, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
araceli.diez-fraile@azsintjan.be |
|
Affiliation:
|
|
|
|
Key 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteonecrosis
|
|
Osteoradionecrosis
|
|
Head and Neck Cancer
|
|
Primary Outcome(s)
|
|
bone resorption, as evaluated with cone-beam computed tomography
[Time Frame: within 12 months postoperative]
|
|
implant survival rate
[Time Frame: within 12 months postoperative]
|
|
prosthesis survival rate
[Time Frame: within 12 months postoperative]
|
|
prosthesis survival rate
[Time Frame: within 60 months postoperative]
|
|
bone resorption, as evaluated with cone-beam computed tomography
[Time Frame: within 60 months postoperative]
|
|
implant survival rate
[Time Frame: within 60 months postoperative]
|
|
Secondary Outcome(s)
|
|
Patient' quality of life after prosthetic rehabilitation
[Time Frame: until a maximum of 60 months follow-up]
|
|
Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
[Time Frame: within 60 months postoperative]
|
|
Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ
[Time Frame: within 12 months postoperative]
|
|
Secondary ID(s)
|
|
B049201525496
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|