Benign or Malignant Tumour of the Oral CavityStage III-IV OsteonecrosisMandibular ReconstructionFixed Dental RestorationQuality of Life
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
EORTC QLQ C30, for measurement of quality of life — 6 weeks after O-bridge placement 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 — 6 weeks after O-bridge placement 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 — 6 months after O-bridge placement 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 — 6 months after O-bridge placement short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35
OHIP, for measurement of quality of life — 6 weeks after O-bridge placement short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
OHIP, for measurement of quality of life — 6 months after O-bridge placement short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
Trial sites (5)
Facility
City
Region
Status
Ziekenhuis Netwerk Antwerpen
Antwerp
Belgium
Recruiting
ZMACK association - Antwerp University Hospital
Antwerp
Belgium
Recruiting
Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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