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Validation of the O-bridge Protocol: a Prospective, Multicenter Trial

Recruitingn/aAges 18 Years - anyAllAZ Sint-Jan AV
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In plain words

What the trial is, and whether it could suit you

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-bridgeยฎ)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

5 sites
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium
ZMACK association - Antwerp University Hospital
Antwerp, Belgium
Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium
University Hospital Leuven
Leuven, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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