NCT04464252

Brief Summary

This study is aimed to develop and assess the validity of an algorithm for automated three-dimensional cephalometry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 17, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

June 17, 2020

Last Update Submit

October 28, 2022

Conditions

Orthognathic SurgeryDentofacial Deformities

Keywords

Imaging, three-dimensionalCephalometryAnatomic LandmarksRadiographic Image InterpretationDeep LearningOrthodontics

Outcome Measures

Primary Outcomes (1)

  • Average distances (in mm) between the points placed automatically and the points placed manually (reference).

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Percentage of points placed automatically within 2 / 3 / 4 mm of the the points placed manually (reference)

    through study completion, an average of 1 year

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care hospital (hopital de la Pitié-Salpêtrière, AP-HP, Paris, France), maxillofacial surgery department

You may qualify if:

  • Patients followed in the maxillofacial surgery department of Pitie-Salpetriere hospital (AP-HP, Paris, France) since 2014;
  • who underwent orthognathic surgery;
  • who had, for surgery planning, a three-dimensional radiographic examination (CT-Scan) which has been segmented for the manufacture of a custom-made device;
  • who did not object to the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Maxillo-Faciale, Service de Chirurgie Maxillo-Faciale

Paris, 75013, France

Location

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

July 9, 2020

Study Start

April 30, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)