Facial DeformityNCT06506695
Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
A study testing Craniofacial implant placement in people with Facial Deformity and Implant Complication, run by University Hospital, Ghent.
Trial summary
Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Deformity, Implant Complication
- What is being tested?
- Craniofacial implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue;
- Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue;
- Patients who can come to the hospital every week for 6 weeks.
Who cannot join
- Patients with insufficient bone mass for implant placement
- Patients who cannot come to the hospital for weekly follow-ups
- Patients that wish an autologous reconstruction
- Patient is unable to tolerate general anesthesia
About this study
Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.
This study aims to achieve two goals:
- To load the implants with a nose or ear prosthesis within one month (preferably <3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.
- Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.
- Conditions
- Facial Deformity, Implant Complication
- Being tested
- Craniofacial implant placement
- Keywords
- Facial defect, Facial Prosthesis, Ear prosthesis, Nose prosthesis, Craniofacial implant, Anaplastology, Prosthesis fabrication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniofacial implant placementDevice
- Resection of oncologic process or remnants after trauma if necessary
- Placement of craniofacial implants in the nasal floor and/or the temporal bone.
- Placement of split thickness skin graft around the implants
- Placement of nose and/or ear prosthesis within 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Early loading of craniofacial prosthesis | Experimental | Not described Receives: Device: Craniofacial implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of implant survival in nasal and temporal bone from 0-100%
Investigate craniofacial implant survival. 100% being better than 0%.
Measured: 6 months after placement of implants
Peri-implant complications using the Holgers' (grade 0-4)
Investigate craniofacial peri-implant complications after early loading concept using the Holgers' scale from 0, meaning excellent peri-implant status to 4 necessitating removal of the implant.
Measured: 6 months after placement of implants
Peri-implant complications using the IPS scale (IPS-score)
Investigate craniofacial peri-implant complications after early loading concept using the IPS scale. Only the 'percutaneous' part of the scale will be used. IPS scale ranges from no treatment to removal of the implant.
Measured: 6 months after placement of implants
Quality of Life with SF-36, SWLS and RSES and self-made questionnaire
Assessing the patient's quality of life using the early loading protocol with standardised and self-made questionnaires. The SF-36 scoring will result in 8 scales ranging from 0-100 with the lower the score the more disability. SWLS will result in a range of 5-35. The higher the score the higher the satisfaction with life. RSES ranges from 0-30. Scores between 15 and 25 are considered in the normal range whereas scores below 15 suggest low self-esteem. The self-made questionnaires will result in percentages of the given answers.
Measured: Before treatment and 6 months after implant placement
Secondary outcomes (3)
Difference in surface matching of the midface and temporal area in mm
By matching and comparing surface scans we can analyse the swelling in the midface and temporal area after directly after surgery and postoperatively. These will result in positive or negative changes and expressed in millimeters.
Measured: 6 months after implant placement
Implant stability over time with implant stability quotient (ISQ) range 1-100
By measuring stability we can create an osseointegration timeline for craniofacial implants. Higher values indicate higher stability. Values in between 55 and 85 are considered acceptable.
Measured: 6 months after implant placement
Feasibility of remote prosthesis fabrication
Questionnaires assessing the experience of the patient and aesthetics of the prosthesis
Measured: 6 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start15 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial DeformityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506695
- Sponsor's protocol ID
- ONZ-2024-0171
- Status last verified
- Jul 2024
- First submitted
- 1 May 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized raw data will be shared with the scientific community. All materials that can be used to identify the patient such as face scans and clinical pictures will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06506695
- Acronym / sponsor ID
- ONZ-2024-0171
- Conditions
- Facial Deformity, Implant Complication
- Keywords
- Facial defect, Facial Prosthesis, Ear prosthesis, Nose prosthesis, Craniofacial implant, Anaplastology, Prosthesis fabrication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.
This study aims to achieve two goals:
- To load the implants with a nose or ear prosthesis within one month (preferably <3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.
- Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early loading of craniofacial prosthesis | Experimental | Device: Craniofacial implant placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue;
- Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue;
- Patients who can come to the hospital every week for 6 weeks.
Key exclusion criteria (4 listed)
- Patients with insufficient bone mass for implant placement
- Patients who cannot come to the hospital for weekly follow-ups
- Patients that wish an autologous reconstruction
- Patient is unable to tolerate general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Craniofacial implant placement* Resection of oncologic process or remnants after trauma if necessary * Placement of craniofacial implants in the nasal floor and/or the temporal bone. * Placement of split thickness skin graft around the implants * Placement of nose and/or ear prosthesis within 3 weeks | Device | Early loading of craniofacial prosthesis |
Primary outcome
Rate of implant survival in nasal and temporal bone from 0-100%
Time frame: 6 months after placement of implants
Investigate craniofacial implant survival. 100% being better than 0%.
Peri-implant complications using the Holgers' (grade 0-4)
Time frame: 6 months after placement of implants
Investigate craniofacial peri-implant complications after early loading concept using the Holgers' scale from 0, meaning excellent peri-implant status to 4 necessitating removal of the implant.
Peri-implant complications using the IPS scale (IPS-score)
Time frame: 6 months after placement of implants
Investigate craniofacial peri-implant complications after early loading concept using the IPS scale. Only the 'percutaneous' part of the scale will be used. IPS scale ranges from no treatment to removal of the implant.
Quality of Life with SF-36, SWLS and RSES and self-made questionnaire
Time frame: Before treatment and 6 months after implant placement
Assessing the patient's quality of life using the early loading protocol with standardised and self-made questionnaires. The SF-36 scoring will result in 8 scales ranging from 0-100 with the lower the score the more disability. SWLS will result in a range of 5-35. The higher the score the higher the satisfaction with life. RSES ranges from 0-30. Scores between 15 and 25 are considered in the normal range whereas scores below 15 suggest low self-esteem. The self-made questionnaires will result in percentages of the given answers.
3 secondary outcomes
Difference in surface matching of the midface and temporal area in mm
Time frame: 6 months after implant placement
Implant stability over time with implant stability quotient (ISQ) range 1-100
Time frame: 6 months after implant placement
Feasibility of remote prosthesis fabrication
Time frame: 6 months after implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes. Anonymized raw data will be shared with the scientific community. All materials that can be used to identify the patient such as face scans and clinical pictures will not be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Craniofacial implant placement in people with Facial Deformity and Implant Complication, run by University Hospital, Ghent.
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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of implant survival in nasal and temporal bone from 0-100% (time frame: 6 months after placement of implants). The study lists 4 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 17 Jul 2024.