NCT05888935

Brief Summary

Dental periapical damages can have various reasons and is reflected by a radiolucent lesion on complementary imaging: angulated retro-alveolar (RA) radiographs, dental panoramic radiographs, and three-dimensional imaging such as computed tomography (CT) or cone-beam computed tomography (CBCT). For the radiographic detection of these deep periodontal lesions, the dental panoramic represents a first approach commonly performed with relatively low radiation. The investigation can be followed by retroalveolar radiology imaging that are more localized and more precise. However, using these techniques, the detection rates of these lesions are low (20% and 36% respectively), it is necessary to use three-dimensional tomographic investigation to be more discriminating (69%). The gold standard imaging for detection of these lesions is CBCT followed by retroalveolar radiography (\~2x less sensitive than CBCT) and panoramic radiography (\~2x less sensitive than RA). Although not a full-thickness radiograph, the dental panoramic has the advantage of being more commonly performed while being less radiating than CBCT and giving a global view of the dental arches on a single image. The detection of periapical lesions is done after a clinical assessment and a visual appreciation of the complementary examinations. The aim of this project is to improve the detection of periapical lesions, by developing an algorithm able to identify them on a panoramic dental radiograph. This algorithm is based on a deep learning system trained with reference data including panoramic dental imaging and CBCT with an acquisition interval of less than 3 months. The model is based on a previous work, will improve the quality of the initial data (using CBCT), using innovative artificial intelligence algorithms (transfer learning).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

May 25, 2023

Last Update Submit

August 7, 2024

Conditions

Keywords

tomographydental injuryartificial intelligenceperiapical lesions

Outcome Measures

Primary Outcomes (1)

  • Artificial Intelligence software performance

    measurement of the F1 score. The F1 score is calculated as the harmonic mean of the precision and recall scores. It ranges from 0-100%, and a higher F1 score denotes a better quality classifier.

    2 years

Secondary Outcomes (1)

  • Artificial Intelligence software specificity

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with periapical lesions

You may qualify if:

  • Patients who have had CBCT and panoramic dental imaging with less than 3 months between the two examinations

You may not qualify if:

  • Patients who refused to participe in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Marc ENGELS-DEUTSCH, MD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR
  • Paul RETIF, MD, PhD

    CHR Metz Thionville Hopital de Mercy

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

October 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations