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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAZ Sint-Jan AV

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
6 weeks after O-bridge placement
2

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

Time frame
6 weeks after O-bridge placement
3

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

Time frame
6 months after O-bridge placement
4

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

Time frame
6 months after O-bridge placement

Secondary outcomes

1

percentage of patients with marginal bone loss around implants

short-term biologic implant stability, measured through OPG imaging

Time frame
until one year post implantation
2

percentage of patients with marginal bone loss around implants

long-term biologic implant stability, measured through OPG imaging

Time frame
until five years post implantation
3

percentage of patients with mechanical stability problems of the prosthesis

short-term, measured through clinical evaluation

Time frame
until one year post implantation
4

percentage of patients with mechanical stability problems of the prosthesis

long-term, measured through clinical evaluation

Time frame
until five years post implantation

Other outcomes

Sponsors and contacts

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