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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06080633
Other study ID # S20230825
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2026

Study information

Verified date June 2024
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with complete edentulism, - aged 50 years or above, - in good physical health, Exclusion Criteria: - patients who refuse to participate in the study, - patients who cannot undergo facial scanning.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Hongyang Ma Leuven Heverlee

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Between pre-operation and after Implant-Supported Fixed Prostheses up to 3 months
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