An observational study in Benign or Malignant Tumour of the Oral Cavity, Stage III-IV Osteonecrosis and Mandibular Reconstruction, sponsored by AZ Sint-Jan AV. Recruiting at 5 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by AZ Sint-Jan AV · Observational
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.
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.
Objective: The investigators aim to demonstrate the added value of the "O-bridge® protocol" in a larger sample size of at least 20 patients eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity (mandibular) reconstruction study design: a prospective, observational cohort study. The "O-bridge® protocol", in which the standardized concept of implant loading and that of oral cavity (mandibular) reconstruction are combined with an adapted prosthetic manufacturing protocol, will be offered to eligible patients requiring ablative surgery because of a benign or malignant tumour of the oral cavity or stage 3-4 osteonecrosis.
All patients will be screened by the local maxillofacial surgeon and the prosthodontist to determine eligibility for the procedure. Imaging will be performed as part of routine surgical preparation. Clinical function, as measured with the 11-item scale by Rogers and intelligibility of speech will be assessed by the speech therapist and/or appointed health care employee prior to surgery, 3 months post-surgery and/or at time of implant placement, and at 6 weeks after placement of the O-bridge®. In addition, EORTC quality of life C30 and HN35 questionnaires will also be completed at those time-points, and at 6 months after placement of the O-bridge®. Speech-, food- and prosthetic fit-related items from the Oral Health Impact Profile (OHIP) questionnaire will be completed at 6 weeks and at 6 months after placement of the O-bridge®. Parameters related to implant and bridge stability and patient satisfaction, measured through a 10-point visual analogue scale, will be assessed at 6, 12, 24, 36, 48 and 60 months at routine follow-up consultation after placement of the O-bridge®.
As a primary endpoint, the investigators aim to demonstrate that the O-bridge® protocol significantly improves short-term patient' quality of life.
Moreover, the investigators aim to demonstrate the validity and reliability of the O-bridge® protocol, based on its short- and long-term biologic implant stability and mechanical stability of the prosthesis. In addition, they aim to measure the impact of the O-bridge® on speech intelligibility.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 80 is below the median of 121 across 127 observational studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →AZ Sint-Jan AV is the lead sponsor of 60 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
OHIP, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
Time frame: 6 weeks after O-bridge placement
OHIP, for measurement of quality of life
short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
Time frame: 6 months after O-bridge placement
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
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
percentage of patients with mechanical stability problems of the prosthesis
short-term, measured through clinical evaluation
Time frame: until one year post implantation
percentage of patients with mechanical stability problems of the prosthesis
long-term, measured through clinical evaluation
Time frame: until five years post implantation
percentage of patients with difficulties in speech intelligibility
impact of the O-bridge on speech intelligiblity, measured through reading of a predefined oronasal text interpreted by the speech and language pathologist
Time frame: prior to and 6 weeks post O-bridge
Plan to share: No
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AZ Sint-Jan AV