Head and Neck CancerO-BRIDGENCT02661139
Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
An observational study of Head and Neck Cancer and Osteonecrosis, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer, Osteonecrosis, Osteoradionecrosis
- How many people
- 55 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Dec 2027
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consenting patients with a histologically confirmed oncology diagnosis that requires major ablative surgery of the oral cavity, including segmental or total jaw resection, due to head and neck cancer, ORN or MRONJ
Who may be able to join
- Patients of all ages
- Patients of all genders
- Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring 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 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 eligible for conventional removable prosthetic rehabilitation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Araceli Diez-Fraile, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
General Hospital Saint-John Bruges
Bruges
Araceli Diez-Fraile, PhD, araceli.diez-fraile@azsintjan.be
About this study
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction
Read the detailed description
The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
- Conditions
- Head and Neck Cancer, Osteonecrosis, Osteoradionecrosis
- Keywords
- bisphosphonates, jaw reconstruction, prosthetic rehabilitation, quality of life, monoclonal antibodies' targeted therapy
- Medical subject headings
- Head and Neck Neoplasms, Osteonecrosis, Osteoradionecrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
implant survival rate
Measured: within 12 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Measured: within 12 months postoperative
prosthesis survival rate
Measured: within 12 months postoperative
implant survival rate
Measured: within 60 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Measured: within 60 months postoperative
prosthesis survival rate
Measured: within 60 months postoperative
Secondary outcomes (3)
Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ
Measured: within 12 months postoperative
Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
Measured: within 60 months postoperative
Patient' quality of life after prosthetic rehabilitation
Measured: until a maximum of 60 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJun 2013
- 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 Head and Neck CancerStudies 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
- 55 participants (estimated)
- Target duration
- 5 Years
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, Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661139
- Sponsor's protocol ID
- B049201525496
- Acronym
- O-BRIDGE
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2016
- Last updated
- 28 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
- ClinicalTrials.gov ID
- NCT02661139
- Acronym / sponsor ID
- O-BRIDGE / B049201525496
- Conditions
- Head and Neck Cancer, Osteonecrosis, Osteoradionecrosis
- Keywords
- bisphosphonates, jaw reconstruction, prosthetic rehabilitation, quality of life, monoclonal antibodies' targeted therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jan 2016 (estimated)
- 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.
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction
Detailed description
The number of patients requiring major ablative surgery in the oral cavity, including partial/radical mandibular or maxillary resection, due to a head and neck carcinoma, osteoradionecrosis (ORN), or medication-related osteonecrosis of the jaw (MRONJ) has not been accurately reported. Surgical reconstruction to restore oral function and aesthetics forms a challenge to maxillofacial surgeons, and greatly impacts patient' quality of life (QOL). Recently, an active collaboration between the surgeons of the Oral and Maxillofacial Surgery Unit and the prosthodontist (LB) of the Department of Dentistry at the General Hospital Saint-John Bruges led to the development of the "Oncology-bridge (O-bridge)" protocol, which offers (immediate/delayed) fixed prosthetic rehabilitation in a minimum of sessions and a strongly reduced two-week treatment time, consequently accelerating patient' improved QOL at a considerably reduced cost.
The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction This could provide the investigators with more information about potential patient, surgical and prosthetic factors influencing short- and long-term biological and mechanical stability, as well as patient QOL. Moreover, registration of those results could function as a measurement of quality of care, and could be used for sample size calculation for future large prospective trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consenting patients with a histologically confirmed oncology diagnosis that requires major ablative surgery of the oral cavity, including segmental or total jaw resection, due to head and neck cancer, ORN or MRONJ
Key inclusion criteria (5 listed)
- Patients of all ages
- Patients of all genders
- Patients with a histologically or clinically confirmed diagnosis of ORN, MRONJ, as classified by Ruggiero et al. (Ruggiero, et al., 2014) or carcinoma located in the oral cavity and jawbone, requiring 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 (3 listed)
- 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 eligible for conventional removable prosthetic rehabilitation
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
implant survival rate
Time frame: within 12 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Time frame: within 12 months postoperative
prosthesis survival rate
Time frame: within 12 months postoperative
implant survival rate
Time frame: within 60 months postoperative
bone resorption, as evaluated with cone-beam computed tomography
Time frame: within 60 months postoperative
prosthesis survival rate
Time frame: within 60 months postoperative
3 secondary outcomes
Prevalence of oncological patients requiring jaw reconstruction secondary to tumour resection, ORN or MRONJ
Time frame: within 12 months postoperative
Potential biologic or mechanical risk factors predictive of undesirable functional or aesthetic outcomes, through regression analysis
Time frame: within 60 months postoperative
Patient' quality of life after prosthetic rehabilitation
Time frame: until a maximum of 60 months follow-up
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 28 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Araceli Diez-Fraile, PhD contact
Johan Abeloos, MD principal investigator
Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Osteonecrosis, run by AZ Sint-Jan AV at 1 site 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 5 inclusion and 3 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 28 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 1 site 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 (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?
implant survival rate (time frame: within 12 months postoperative). 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 28 Feb 2022.