Dental CariesNCT06428344
Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
An observational study of Dental Caries and Artificial Intellegence, run by Zhejiang Provincial People's Hospital.
Trial summary
This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Caries, Artificial Intellegence, Diagnosis
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting the all the three centers during the study period with symptoms of caries as their chief complaint.
Who may be able to join
- -
- Patients presenting with clinical manifestations of caries as their chief complaint;
- Age ≥18 and ≤70 years, irrespective of gender;
- Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
- On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
- Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts;
- Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form.
Who cannot join
- Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
- Insufficient number of teeth available for study;
- Severe tooth wear or erosion leading to significant alteration in tooth morphology;
- Presence of supernumerary teeth, microdontia, or missing teeth;
- Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
- Limited mouth opening that precludes clinical examination;
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- Neurological disorders, psychiatric illnesses, or psychological impairments;
- Participation in another clinical trial within the last three months;
- Any other condition deemed by the researchers as unsuitable for inclusion in the study.
About this study
This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.
- Conditions
- Dental Caries, Artificial Intellegence, Diagnosis, Machine Learning
- Keywords
- Dental Caries, AI Diagnosis
- Medical subject headings
- Dental Caries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Dentist specializing in endodontics with over five years of experience independently reviewed the participants' oral panoramic radiographs in a random order. | |
| Trial group | The diagnoses of caries on oral panoramic radiographs were made with the assistance of an artificial intelligence-aided oral panoramic diagnostic system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, and accuracy of caries diagnosis
Sensitivity: Sensitivity assesses the diagnostic method's ability to identify the disease, that is, how many true cases of caries can be correctly identified among all actual cases of caries.
Specificity: Specificity evaluates the diagnostic tool's ability to recognize the absence of disease, meaning how many true non-caries cases can be correctly identified among all actual non-caries cases.
Accuracy: Accuracy evaluates the overall correctness of the diagnostic tool in diagnosing the disease.
Measured: Immediately after the completion of all participant information collection.
Secondary outcomes (2)
Miss rate and false positive rate of caries diagnosis
Miss rate (False Negative Rate): The miss rate refers to the proportion of true caries cases that the diagnostic method fails to correctly identify among all actual cases of caries. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the miss rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience.
False positive rate: The false positive rate refers to the proportion of cases that are incorrectly identified as having caries among all actual non-caries cases. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the false positive rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience.
Measured: Immediately after the completion of all participant information collection.
Accuracy of Caries Severity Level Diagnosis
This study utilizes the International Caries Detection and Assessment System (ICDAS) to evaluate the grading of caries severity, categorizing caries severity into five levels: E0, E1, E2, D1, and D2. Wherein: E0 indicates no apparent signs of caries; E1 represents early caries, primarily initial enamel lesions; E2 designates enamel caries without involvement of the dentin; D1 denotes superficial dentin caries, not reaching half of the dentin thickness; D2 signifies deep dentin caries, reaching or exceeding half of the dentin thickness. This study will assess and compare the diagnostic accuracy at each grading level between the trial group and the control group.
Measured: Immediately after the completion of all participant information collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Yang, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428344
- Sponsor's protocol ID
- KY2024060
- Status last verified
- Jul 2024
- First submitted
- 20 May 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06428344
- Acronym / sponsor ID
- KY2024060
- Conditions
- Dental Caries, Artificial Intellegence, Diagnosis, Machine Learning
- Keywords
- Dental Caries, AI Diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Dentist specializing in endodontics with over five years of experience independently reviewed the participants' oral panoramic radiographs in a random order. |
| Trial group | – | –The diagnoses of caries on oral panoramic radiographs were made with the assistance of an artificial intelligence-aided oral panoramic diagnostic system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the all the three centers during the study period with symptoms of caries as their chief complaint.
Key inclusion criteria (7 listed)
- -
- Patients presenting with clinical manifestations of caries as their chief complaint;
- Age ≥18 and ≤70 years, irrespective of gender;
- Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant;
- On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant;
Key exclusion criteria (9 listed)
- Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present;
- Insufficient number of teeth available for study;
- Severe tooth wear or erosion leading to significant alteration in tooth morphology;
- Presence of supernumerary teeth, microdontia, or missing teeth;
- Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity, and accuracy of caries diagnosis
Time frame: Immediately after the completion of all participant information collection.
Sensitivity: Sensitivity assesses the diagnostic method's ability to identify the disease, that is, how many true cases of caries can be correctly identified among all actual cases of caries. Specificity: Specificity evaluates the diagnostic tool's ability to recognize the absence of disease, meaning how many true non-caries cases can be correctly identified among all actual non-caries cases. Accuracy: Accuracy evaluates the overall correctness of the diagnostic tool in diagnosing the disease.
2 secondary outcomes
Miss rate and false positive rate of caries diagnosis
Time frame: Immediately after the completion of all participant information collection.
Accuracy of Caries Severity Level Diagnosis
Time frame: Immediately after the completion of all participant information collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Artificial Intellegence, run by Zhejiang Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, and accuracy of caries diagnosis (time frame: Immediately after the completion of all participant information collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.