Edentulous JawNCT06080633
Facial Prediction Technology for Edentulous Patients
An observational study of Edentulous Jaw, run by KU Leuven at 1 site in Belgium.
Trial summary
According to data from the World Health Organization, approximately 160 million people worldwide are edentulous. The incidence increases with age, and the proportion of edentulous patients is higher in the population aged 60 and above. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 1 Dec 2026
- 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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with Edentulous Maxilla after Implant Prosthetic Restoration
Who may be able to join
- Patients with complete edentulism,
- aged 50 years or above,
- in good physical health,
Who cannot join
- patients who refuse to participate in the study，
- patients who cannot undergo facial scanning.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hongyang Ma
Leuven, Heverlee, 3000
Hongyang Ma, 0486495457, mahongyang1991@foxmail.com
About this study
Official title: Research on Facial Prediction Technology for Edentulous Implant-Supported Fixed Prostheses Based on Multimodal Data Fusion
According to data from the World Health Organization, approximately 160 million people worldwide are edentulous. The incidence increases with age, and the proportion of edentulous patients is higher in the population aged 60 and above. Loss of teeth or edentulism can affect facial appearance, causing people to feel self-conscious and loss confidence in social situations, and even lead to psychological illnesses. Therefore, edentulous patients not only pay close attention to the recovery of oral function but also attach great importance to facial contour improvement. For a long time, due to technological limitations, clinicians have been unable to depict the changes in facial contour after implant placement for patients before surgery. However, with the development of artificial intelligence technology, deep learning-based methods for predicting soft tissue facial deformation have made this mission a possibility. This study established a multi-modal dataset for edentulous patients before and after implant restoration to lay the foundation for predicting facial contour changes after implant treatment. A graph generative adversarial network based on multi-modal data was proposed to achieve fast and high-precision facial contour prediction. To address the common challenges of slow computation and excessive computational resource consumption in current triangular mesh deformation simulation methods, this project innovatively proposed a graph generative adversarial network that uses multi-modal data and incorporates self-attention mechanisms to achieve fast and high-precision facial contour prediction for edentulous patients after implant restoration.
- Conditions
- Edentulous Jaw
- Keywords
- Edentulous Jaw, deep learning, oral implantology, facial prediction
- Medical subject headings
- Jaw, Edentulous
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Soft Tissue Volume in the Lip Region after Implant Dentistry
Quantitative analysis of lip volume changes in patients after oral implant surgery using facial scanning equipment
Measured: Between pre-operation and after Implant-Supported Fixed Prostheses up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyang Ma, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080633
- Sponsor's protocol ID
- S20230825
- Status last verified
- Jun 2024
- First submitted
- 29 Aug 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Facial Prediction Technology for Edentulous Implant-Supported Fixed Prostheses Based on Multimodal Data Fusion
- ClinicalTrials.gov ID
- NCT06080633
- Acronym / sponsor ID
- S20230825
- Conditions
- Edentulous Jaw
- Keywords
- Edentulous Jaw, deep learning, oral implantology, facial prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (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.
According to data from the World Health Organization, approximately 160 million people worldwide are edentulous. The incidence increases with age, and the proportion of edentulous patients is higher in the population aged 60 and above. Loss of teeth or edentulism can affect facial appearance, causing people to feel self-conscious and loss confidence in social situations, and even lead to psychological illnesses. Therefore, edentulous patients not only pay close attention to the recovery of oral function but also attach great importance to facial contour improvement. For a long time, due to technological limitations, clinicians have been unable to depict the changes in facial contour after implant placement for patients before surgery. However, with the development of artificial intelligence technology, deep learning-based methods for predicting soft tissue facial deformation have made this mission a possibility. This study established a multi-modal dataset for edentulous patients before and after implant restoration to lay the foundation for predicting facial contour changes after implant treatment. A graph generative adversarial network based on multi-modal data was proposed to achieve fast and high-precision facial contour prediction. To address the common challenges of slow computation and excessive computational resource consumption in current triangular mesh deformation simulation methods, this project innovatively proposed a graph generative adversarial network that uses multi-modal data and incorporates self-attention mechanisms to achieve fast and high-precision facial contour prediction for edentulous patients after implant restoration.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Edentulous Maxilla after Implant Prosthetic Restoration
Key inclusion criteria (3 listed)
- Patients with complete edentulism,
- aged 50 years or above,
- in good physical health,
Key exclusion criteria (2 listed)
- patients who refuse to participate in the study，
- patients who cannot undergo facial scanning.
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
Changes in Soft Tissue Volume in the Lip Region after Implant Dentistry
Time frame: Between pre-operation and after Implant-Supported Fixed Prostheses up to 3 months
Quantitative analysis of lip volume changes in patients after oral implant surgery using facial scanning equipment
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 13 Jun 2024.
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
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 Edentulous Jaw, run by KU Leuven 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 3 inclusion and 2 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 13 Jun 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Soft Tissue Volume in the Lip Region after Implant Dentistry (time frame: Between pre-operation and after Implant-Supported Fixed Prostheses up to 3 months). 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 13 Jun 2024.