Benign or Malignant Tumour of the Oral CavityNCT04007783
Validation of the O-bridge Protocol: a Prospective, Multicenter Trial
An observational study of Benign or Malignant Tumour of the Oral Cavity and Stage III-IV Osteonecrosis, run by AZ Sint-Jan AV at 5 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign or Malignant Tumour of the Oral Cavity, Stage III-IV Osteonecrosis, Mandibular Reconstruction
- How many people
- 80 participants
- Where
- 5 sitesBelgium
- Study dates
- 4 Mar 2017to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Ziekenhuis Netwerk Antwerpen
Antwerp
Olivier Lenssen, MD
- Recruiting
ZMACK association - Antwerp University Hospital
Antwerp
Wouter De Vos, MD
Elke Van de Casteele, MSc, PhD
- Recruiting
Division of Oral and Maxillofacial Surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges
Araceli Diez-Fraile, VMD MSc PhD
- Recruiting
University Hospital Leuven
Leuven
Constantinus Politis, MD, PhD
- Recruiting
AZ Nikolaas
Sint-Niklaas
Kristof Hendrickx, MD
About this study
Official title: Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter 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.
Read the detailed description
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after O-bridge placement
Secondary outcomes (5)
percentage of patients with marginal bone loss around implants
short-term biologic implant stability, measured through OPG imaging
Measured: until one year post implantation
percentage of patients with marginal bone loss around implants
long-term biologic implant stability, measured through OPG imaging
Measured: until five years post implantation
percentage of patients with mechanical stability problems of the prosthesis
short-term, measured through clinical evaluation
Measured: until one year post implantation
percentage of patients with mechanical stability problems of the prosthesis
long-term, measured through clinical evaluation
Measured: 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
Measured: prior to and 6 weeks post O-bridge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Mar 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign or Malignant Tumour of the Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, AZ Sint-Lucas Brugge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007783
- Sponsor's protocol ID
- B322201731284
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the O-bridge Protocol, Ensuring Immediate or Delayed Prosthetic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction: a Prospective, Multicenter Trial
- ClinicalTrials.gov ID
- NCT04007783
- Acronym / sponsor ID
- B322201731284
- Conditions
- Benign or Malignant Tumour of the Oral Cavity, Stage III-IV Osteonecrosis, Mandibular Reconstruction, Fixed Dental Restoration, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EORTC QLQ C30, for measurement of quality of life
Time frame: 6 weeks after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30 questionnaire
EORTC QLQ H&N35, for measurement of quality of life
Time frame: 6 weeks after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35 questionnaire
EORTC QLQ C30, for measurement of quality of life
Time frame: 6 months after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ C30
EORTC QLQ H&N35, for measurement of quality of life
Time frame: 6 months after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the EORTC QLQ HN35
OHIP, for measurement of quality of life
Time frame: 6 weeks after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
OHIP, for measurement of quality of life
Time frame: 6 months after O-bridge placement
short-term quality of life after dental restoration with the O-bridge, measured through the OHIP questionnaire
5 secondary outcomes
percentage of patients with marginal bone loss around implants
Time frame: until one year post implantation
percentage of patients with marginal bone loss around implants
Time frame: until five years post implantation
percentage of patients with mechanical stability problems of the prosthesis
Time frame: until one year post implantation
percentage of patients with mechanical stability problems of the prosthesis
Time frame: until five years post implantation
percentage of patients with difficulties in speech intelligibility
Time frame: prior to and 6 weeks post O-bridge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Benign or Malignant Tumour of the Oral Cavity
Recruiting
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan Abeloos, MD principal investigator
AZ Sint-Lucas Brugge
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign or Malignant Tumour of the Oral Cavity and Stage III-IV Osteonecrosis, run by AZ Sint-Jan AV at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Araceli Diez-Fraile, PhD (0032(0)50459660, araceli.diez-fraile@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ C30, for measurement of quality of life (time frame: 6 weeks after O-bridge placement). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.