NCT06022731

Brief Summary

The goal of this Non-Interventional Clinical Research is to detect the prevalence and distribution of filling and overhanging filling without the need for additional bitewing radiographs using panoramic images, based on a deep CNN (Convolutional Neural Network) architecture trained through supervised learning. In this study, retrospectively obtained radiographs were used in the development of artificial intelligence models for relevant situations. These datasets were obtained from the images of the patients who applied to ESOGU (Eskişehir Osmangazi University) Dentistry Faculty, Dentomaxillofacial Radiology clinic for various dental purposes. Eskisehir Osmangazi University Non-Interventional Clinical Research Ethics Board (decision date and decision number: 04.10.2022/22) approved the study protocol. The principles of the Helsinki Declaration were followed in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 8, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

dental fillingdentistrydeep learning,

Outcome Measures

Primary Outcomes (1)

  • The success of artificial intelligence models for filling and overhanging filling

    It is obtained by calculating the sensitivity, precision, and F1 scores values for filling and overhanging filling.

    1 year

Study Arms (2)

Filling

Diagnostic Test: Panoramic Radiography

Overhanging Filling

Diagnostic Test: Panoramic Radiography

Interventions

Panoramic RadiographyDIAGNOSTIC_TEST

this retrospective study includes analysis of radiographs previously taken from patients for various purposes

FillingOverhanging Filling

Eligibility Criteria

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

These datasets were obtained from the images of the patients who applied to ESOGU Dentistry Faculty, Dentomaxillofacial Radiology clinic for various dental purposes.

You may qualify if:

  • Images of individuals in the permanent dentition period
  • Artifact-free images in the examination region
  • Individuals with a history of restorative dental treatment

You may not qualify if:

  • Images of individuals in mixed dentition
  • Radiographic images obtained by incorrect positioning of the patient or containing artifacts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Radiography, Panoramic

Intervention Hierarchy (Ancestors)

Radiography, DentalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnosis, OralDentistry

Study Design

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

Study Record Dates

First Submitted

August 8, 2023

First Posted

September 5, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

The investigators plan to publish the findings obtained as a result of the study in internationally journals and share this information within the publication.

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations