RecruitingNCT04007783

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

Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial

Sponsor

AZ Sint-Jan AV

Enrollment

80 participants

Start Date

Mar 4, 2017

Study Type

OBSERVATIONAL

Conditions

Quality of Life Mandibular Reconstruction Benign or Malignant Tumour of the Oral Cavity Stage III-IV Osteonecrosis Fixed Dental Restoration

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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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