Pulp and Periapical Tissue DiseaseNCT07732985
Comparative Analysis of Diagnostic Accuracy and Case Difficulty Assessment of Three Large Language Models
An observational study of Pulp and Periapical Tissue Disease, run by Cairo University.
Trial summary
This prospective, blinded diagnostic accuracy study aims to compare the performance of three large language models-ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7-in endodontic diagnosis and case difficulty assessment. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulp and Periapical Tissue Disease
- What is being tested?
- ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, Claude Opus 4.7
- Type of treatment
- Medical device
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Jan 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Systemically healthy adult patients (≥16 years) requiring primary endodontic treatment or retreatment at the Endodontic Department, Faculty of Dentistry, Cairo University, who provide informed consent.
Who may be able to join
- Age above 16 years old.
- Systemically healthy patient (ASA I or II).
- Requiring endodontic treatment or retreatment
- Patient's acceptance to participate in the study
Who cannot join
- Medically compromised patients.
- Pregnant women.
- Traumatic dental injuries
- Low quality periapical radiograph
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Diagnostic Accuracy and Case Difficulty Assessment of Three Large Language Models in Endodontics Using Expert Consensus as the Reference Standard
This prospective, blinded diagnostic accuracy study aims to compare the performance of three large language models-ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7-in endodontic diagnosis and case difficulty assessment. The models will be evaluated against expert consensus as the reference standard using standardized clinical data and periapical radiographs. Diagnostic accuracy, sensitivity, specificity, and agreement with expert consensus will be assessed to determine the potential of LLMs as clinical decision-support tools in endodontics.
Read the detailed description
This prospective, blinded diagnostic accuracy study aims to compare the diagnostic accuracy and endodontic case difficulty assessment of three LLMs-ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7-with expert consensus as the reference standard. Adult patients requiring primary endodontic treatment or retreatment will undergo routine clinical examination, pulp sensibility testing, and periapical radiographic assessment. Standardized clinical information and radiographs will be provided to each LLM and to four experienced endodontists independently. Expert consensus, defined as agreement among at least three of four experts, will serve as the reference standard. The primary outcomes are diagnostic accuracy, sensitivity, specificity, and agreement with expert consensus for pulpal and periapical diagnosis and endodontic case difficulty assessment according to the American Association of Endodontists (AAE) criteria. The findings will provide evidence regarding the reliability of LLMs as clinical decision-support tools in endodontics and their potential role in improving diagnostic consistency and treatment planning.
- Conditions
- Pulp and Periapical Tissue Disease
- Being tested
- ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, Claude Opus 4.7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, Claude Opus 4.7Device
Large language model used to analyze standardized clinical information and periapical radiographs to provide pulpal and periapical diagnosis and endodontic case difficulty assessment according to AAE criteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7 for pulpal and periapical diagnosis
Diagnostic performance of each large language model compared with the expert consensus reference standard. Accuracy, sensitivity, specificity, and agreement (Cohen's kappa) will be calculated according to the American Association of Endodontists (AAE) diagnostic criteria
Measured: At baseline
Secondary outcomes (1)
Accuracy of ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7 in endodontic case difficulty assessment
Agreement between each large language model and the expert consensus in classifying endodontic case difficulty according to the AAE Endodontic Case Difficulty Assessment Guidelines. Overall accuracy and weighted Cohen's kappa will be calculated.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp and Periapical Tissue DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ahmed Hossam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732985
- Sponsor's protocol ID
- New ENDO7.1.1
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Diagnostic Accuracy and Case Difficulty Assessment of Three Large Language Models in Endodontics Using Expert Consensus as the Reference Standard
- ClinicalTrials.gov ID
- NCT07732985
- Acronym / sponsor ID
- New ENDO7.1.1
- Conditions
- Pulp and Periapical Tissue Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Jul 2026 (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 prospective, blinded diagnostic accuracy study aims to compare the performance of three large language models-ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7-in endodontic diagnosis and case difficulty assessment. The models will be evaluated against expert consensus as the reference standard using standardized clinical data and periapical radiographs. Diagnostic accuracy, sensitivity, specificity, and agreement with expert consensus will be assessed to determine the potential of LLMs as clinical decision-support tools in endodontics.
Detailed description
This prospective, blinded diagnostic accuracy study aims to compare the diagnostic accuracy and endodontic case difficulty assessment of three LLMs-ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7-with expert consensus as the reference standard. Adult patients requiring primary endodontic treatment or retreatment will undergo routine clinical examination, pulp sensibility testing, and periapical radiographic assessment. Standardized clinical information and radiographs will be provided to each LLM and to four experienced endodontists independently. Expert consensus, defined as agreement among at least three of four experts, will serve as the reference standard. The primary outcomes are diagnostic accuracy, sensitivity, specificity, and agreement with expert consensus for pulpal and periapical diagnosis and endodontic case difficulty assessment according to the American Association of Endodontists (AAE) criteria. The findings will provide evidence regarding the reliability of LLMs as clinical decision-support tools in endodontics and their potential role in improving diagnostic consistency and treatment planning.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Systemically healthy adult patients (≥16 years) requiring primary endodontic treatment or retreatment at the Endodontic Department, Faculty of Dentistry, Cairo University, who provide informed consent.
Key inclusion criteria (4 listed)
- Age above 16 years old.
- Systemically healthy patient (ASA I or II).
- Requiring endodontic treatment or retreatment
- Patient's acceptance to participate in the study
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Pregnant women.
- Traumatic dental injuries
- Low quality periapical radiograph
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, Claude Opus 4.7Large language model used to analyze standardized clinical information and periapical radiographs to provide pulpal and periapical diagnosis and endodontic case difficulty assessment according to AAE criteria | Device | – |
Primary outcome
Diagnostic accuracy of ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7 for pulpal and periapical diagnosis
Time frame: At baseline
Diagnostic performance of each large language model compared with the expert consensus reference standard. Accuracy, sensitivity, specificity, and agreement (Cohen's kappa) will be calculated according to the American Association of Endodontists (AAE) diagnostic criteria
1 secondary outcome
Accuracy of ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7 in endodontic case difficulty assessment
Time frame: At baseline
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 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulp and Periapical Tissue Disease, run by Cairo University.
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 4 inclusion and 4 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 29 Jul 2026. 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?
Contact Mariam Ahmed Hossam (00201110913251, mariam.ahmed.hosam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of ChatGPT (GPT-5.5 Pro), Gemini 3.1 Pro, and Claude Opus 4.7 for pulpal and periapical diagnosis (time frame: At baseline). 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 29 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.