An observational study in Head and Neck Cancer, Osteonecrosis and Osteoradionecrosis, sponsored by AZ Sint-Jan AV. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2022-02-28.
Sponsored by AZ Sint-Jan AV · Observational
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction
The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 55 is below the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →AZ Sint-Jan AV is the lead sponsor of 60 studies on the registry; 14 are open to participants now.
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All consenting patients with a histologically confirmed oncology diagnosis that requires major ablative surgery of the oral cavity, including segmental or total jaw resection, due to head and neck cancer, ORN or MRONJ
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
implant survival rate
Time frame: within 12 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Time frame: within 12 months postoperative
prosthesis survival rate
Time frame: within 12 months postoperative
implant survival rate
Time frame: within 60 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Time frame: within 60 months postoperative
prosthesis survival rate
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
Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
Time frame: within 60 months postoperative
Patient' quality of life after prosthetic rehabilitation
Time frame: until a maximum of 60 months follow-up
patient satisfaction, as measured through visual analogue scale
Time frame: until a maximum of 60 months follow-up
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2013, a primary completion of Dec 2022 and a completion of Dec 2027. It does not say whether these dates are actual or estimated.
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AZ Sint-Jan AV