NCT06080633

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

August 29, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

Edentulous Jawdeep learningoral implantologyfacial prediction

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with Edentulous Maxilla after Implant Prosthetic Restoration

You may qualify if:

  • Patients with complete edentulism,
  • aged 50 years or above,
  • in good physical health,

You may not qualify if:

  • patients who refuse to participate in the study,
  • patients who cannot undergo facial scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hongyang Ma

Leuven, Heverlee, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 29, 2023

First Posted

October 12, 2023

Study Start

June 1, 2023

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations