Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign or Malignant Tumour of the Oral Cavity | — | UNRESOLVED | — |
| Fixed Dental Restoration | — | UNRESOLVED | — |
| Mandibular Reconstruction | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Stage III-IV Osteonecrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- EORTC QLQ C30, for measurement of quality of life
- timeFrame
- 6 weeks after O-bridge placement
- description
- short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30 questionnaire
- measure
- EORTC QLQ H&N35, for measurement of quality of life
- timeFrame
- 6 weeks after O-bridge placement
- description
- short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35 questionnaire
- measure
- EORTC QLQ C30, for measurement of quality of life
- timeFrame
- 6 months after O-bridge placement
- description
- short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available