NCT06450938

Brief Summary

Developing neural network-based models for image analysis can be time-consuming, requiring dataset design and model training. No-code AI platforms allow users to annotate object features without coding. Corrective annotation, a "human-in-the-loop" approach, refines AI segmentations iteratively. Dentistry has seen success with no-code AI for segmenting dental restorations. This study aims to assess radiographic features related to root canal treatment quality using a "human-in-the-loop" approach.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Status
not yet 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

First Submitted

Initial submission to the registry

May 25, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

May 25, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Artificial IntelligenceEndodontic treatment

Outcome Measures

Primary Outcomes (3)

  • Accuracy

    Accuracy represents how closely a result aligns with the true value or standard. Accuracy of participants at experiment and control group in correctly finding the radiographic features and predicting the outcomes is one of our primary outcomes. the reference for the comparison is the consensus of three experts in dentistry.

    through data collection, an average of 6 months

  • Sensitivity

    This measure quantifies the proportion of true positive results (correctly identified cases) out of all positive cases. High sensitivity indicates that one is good at detecting the condition. Sensitivity of participants at experiment and control group in correctly finding the radiographic features and predicting the outcomes is one of our primary outcomes. The comparison is made against the consensus judgment of three experts in dentistry.

    through data collection, an average of 6 months

  • Specificity

    Specificity measures the proportion of true negative results out of all negative cases. Specificity of participants at experiment and control group in correctly finding the radiographic features and predicting the outcomes is one of our primary outcomes. The comparison is made against the consensus judgment of three experts in dentistry.

    through data collection, an average of 6 months

Study Arms (2)

participants using guidance from artificial Intelligence

EXPERIMENTAL

the experimental arm refers to the group of participants who have access to the AI-based platform for detecting features associated with the technical quality of endodontic treatment. These participants will utilize the AI assistance during the study.

Device: AI guidance for finding radiographic features

Control arm without any guidance from artificial Intelligence

NO INTERVENTION

the control arm consists of participants who do not have access to the AI-based platform. They will perform the same tasks or assessments as those in the experimental arm but without the assistance of AI.

Interventions

A secured website was made for the trial in which each student could log in using the assigned number. All the image datasets were uploaded to this website. The students will be randomly assigned to the experiment and control group. Both students were asked to segment the features associated with the quality of root canal treatment and predict the prognosis of treatment while the experiment group had access to AI guidance and the control group didn't.

participants using guidance from artificial Intelligence

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a last year dental student at the university of Copenhagen

You may not qualify if:

  • Having any previous AI-related experiences
  • Not accepting to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, NonvitalPeriapical Periodontitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesPeriapical DiseasesJaw DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Officials

  • Lars Bjørndal, Prof.

    University of Copenhagen Department of Odontology Cariology and Endodontics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaqayeq Ramezanzade, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 25, 2024

First Posted

June 10, 2024

Study Start

July 30, 2024

Primary Completion

November 13, 2024

Study Completion

December 13, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share