NCT06258798

Brief Summary

This cross-sectional study aims to perform a population-based assessment of the incidence of decay, dental fillings, root canal fillings, endodontic lesions, implants, implant and dental abutment crowns, pontic crowns, and missing teeth, taking into account the location.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,025

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

January 25, 2024

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sensitivity

    Sensitivity (also known as recall or true positive rate) is the proportion of actual positive cases that are correctly predicted as positive. It evaluates the performance of an AI algorithm. Formally it can be calculated with the following equation: Sensitivity = TP / (TP+FN) True positive (TP) - a test result that correctly indicates the presence of a condition or characteristic False Negative (FN) - a test result which wrongly indicates that a particular condition or characteristic is absent

    Up to 6 weeks

  • Specificity

    Specificity (also known as true negative rate) - is the proportion of actual negative cases that are correctly predicted as negative. It evaluates the performance of an AI algorithm. Formally it can be calculated by the equation below: Specificity = TN / (TN + FP) True negative (TN) - a test result that correctly indicates the absence of a condition or characteristic False positive (FP) - a test result which wrongly indicates that a particular condition or characteristic is present

    Up to 6 weeks

  • Precision of the AI algorithm

    Precision is an evaluation metric used to assess the performance of machine learning algorithm for AI. It measures how accurate the algorithm is. We will use the number of true positives (TP) and false positives (FP) to calculate precision using the following formula: Precision = TP / (TP + FP) True positive (TP) - a test result that correctly indicates the presence of a condition or characteristic False positive (FP) - a test result that wrongly indicates that a particular condition or characteristic is present

    Up to 6 weeks

Study Arms (1)

One group of patients (double gate)

Study design: * Direction of data collection: retrospective * Number of gates (sets of eligibility criteria): double gate (AI, human) * Participant sampling method: Consecutive * Method of allocating participants to index tests: Each participant received all index tests * Number of reference standards: Single test standard * Limited verification: Full verification (not limited)

Radiation: Taking a dental X-ray

Interventions

Dental X-rays taken in patients with indications confirmed by a written referral.

One group of patients (double gate)

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients included in the study were admitted to the radiology department in Kielce, a city in southern Poland with around 200.000 inhabitants.

You may qualify if:

  • Indications for dental X-ray confirmed by a written referral from the dentist or physician (both screening tests and tests performed for treatment purposes were allowed)
  • Permanent dentition (after exfoliation is completed)

You may not qualify if:

  • Patients with mixed dentition (exfoliation has not finished)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Maxillofacial Surgery

Kielce, 25-375, Poland

Location

Related Publications (1)

  • Turosz N, Checinska K, Checinski M, Lubecka K, Blizniak F, Sikora M. Artificial Intelligence (AI) Assessment of Pediatric Dental Panoramic Radiographs (DPRs): A Clinical Study. Pediatr Rep. 2024 Sep 11;16(3):794-805. doi: 10.3390/pediatric16030067.

MeSH Terms

Conditions

Dental CariesPeriapical DiseasesTooth Loss

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesJaw DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Maciej Sikora

    Hospital of the Ministry of Interior, Wojska Polskiego 51, 25-375 Kielce, Poland

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 14, 2024

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

November 1, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations