About this trial
Surgical reconstruction to restore oral function and aesthetics after major ablative surgery in the oral cavity forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). The "Oncological-bridge (O-bridge®)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
ORN, MRONJ, benign or malignant tumour in the head and neck region requiring ablative oral cavity resection including marginal, segmental or total bony jaw resection
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
EORTC QLQ C30, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30 questionnaire
EORTC QLQ H&N35, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35 questionnaire
EORTC QLQ C30, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30
EORTC QLQ H&N35, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35
Secondary outcomes
percentage of patients with marginal bone loss around implants
short-term biologic implant stability, measured through OPG imaging
percentage of patients with marginal bone loss around implants
long-term biologic implant stability, measured through OPG imaging
percentage of patients with mechanical stability problems of the prosthesis
short-term, measured through clinical evaluation
percentage of patients with mechanical stability problems of the prosthesis
long-term, measured through clinical evaluation
Sponsors and contacts
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