General Hospital Saint-John Bruges
Bruges, Belgium
Location status: Recruiting
NCT Number: NCT02661139
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
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Observational
Bruges, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 12 months postoperative
Time frame: within 12 months postoperative
Time frame: within 12 months postoperative
Time frame: within 60 months postoperative
Time frame: within 60 months postoperative
Time frame: within 60 months postoperative
Time frame: within 12 months postoperative
Time frame: within 60 months postoperative
Time frame: until a maximum of 60 months follow-up
Time frame: until a maximum of 60 months follow-up
Contact information is provided by the study sponsor or research team.
AZ Sint-Jan AV
Other
Acronym: O-BRIDGE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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