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PeriodontitisNCT06306677

Accuracy of an AI-clinical Knowledge-based Hybrid System for Detecting Periodontitis in OPG Images

An observational study of Periodontitis and Periodontal Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontitis, Periodontal Diseases
What is being tested?
AI-clincial-based hybrid system for radiographic image analysis
How many people
1,200 participants
Where
3 sitesin 3 countries
Study dates
12 Mar 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 1. Patients seeking care at Shanghai Ninth People's Hospital Pudong Clinics; 2. Patients seeking care at Shanghai Ninth People's Hospital South Clinics; 3. Patients seeking care at Prince Philip Dental Hospital in Hong Kong; 4. Patients seeking care at The University of Rome La Sapienza in Italy;

Who may be able to join

  • Aged 18 and above
  • Having taken the OPG image

Who cannot join

  • Edentulous mouth

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

China1 site, 1 recruiting
  • Shanghai Perio-Implant Innovation Center

    Shanghai, Shanghai Municipality, 201206

    Yuan Li, 13916337473, ly9919@hotmail.com

    Recruiting

Other trials in China

Hong Kong1 site, 1 recruiting
  • Prince Philip Dental Hospital

    Hong Kong

    George Pelekos, george74@hku.hk

    Recruiting

Other trials in Hong Kong

Italy1 site, 1 recruiting
  • La Sapienza Dental School

    Roma

    Lorenzo Marini, lorenzo.marini@uniroma1.it

    Recruiting

Other trials in Italy

About this study

Official title: What is the Diagnostic Accuracy of a AI-clinical Knowledge Based Hybrid System for the Diagnosis of Stage II-IV Periodontitis Using OPG Images?A Multi-center Study

Periodontitis is highly prevalent and rarely detected and treated in the earlier stages of the disease. Orthopantomography (OPG) is the most frequently taken dental radiograph around the world, and its systematic screening may contribute to early detection of periodontitis and access to the needed level of care. The investigators' recent study initially developed an AI-clinical knowledge-based system for automatic periodontitis diagnosis and indicated good performance for differentiating stage II-IV periodontitis. This cross-sectional diagnostic study aims to compare the diagnostic accuracy of this AI-clinical knowledge-based hybrid system (Index test) with human experts (reference test) for differentiating stage II-IV periodontitis using the OPG images obtained from different 4 centers around the world.

Read the detailed description

Periodontitis is a major public health problem due to its high prevalence worldwide, substantial socio-economic impacts, and considerable effects on individuals' quality of life. However, periodontitis in the population remains largely undetected. It is crucial to raise awareness about periodontal health and enhance early diagnosis of periodontitis to ensure timely intervention.

The 2018 Classification of Periodontal and Peri-implant Diseases and Conditions defines four stages of periodontitis ranging from the initial stage (stage I) to the advanced stage (stage IV). In stages II-IV, comprehensive treatment procedures are essential otherwise there is a high risk of tooth or even the entire dentition loss. Although clinical examinations are regarded as the gold standard for determining the stage of periodontitis, the process is laborious and time-consuming, demanding highly experienced specialists. Therefore, alternative cost-effective but reliable and valid approaches for differentiating stage II-IV periodontitis diagnosis, particularly in public communities are highly needed.

Orthopantomography (OPG), also known as panoramic radiography, is a non-invasive and low-dose imaging technique that provides a comprehensive view of the maxillofacial region in one procedure. As an extraoral radiograph, it has advantages in capturing the image, especially in cases where patients struggle to open their mouths or exhibit a pronounced gag reflex that hinders the use of intraoral films. Thus, OPG is likely the most frequently taken dental radiograph around the world and may potentially serve as an effective tool for differentiating stage II-IV periodontitis in populations. Recently, several investigations have been carried out to utilize OPG images for periodontitis diagnosis. However, the strategies of these studies rely on the radiographic annotations for specific landmarks by clinicians which may lack compelling accuracy. Furthermore, only the radiographs with high quality could be a valuable adjunct for the periodontitis diagnosis, so many available OPG images with the superimposition of anatomical structures, disproportionate image magnification, distortion, and blur may decrease the generalization of the developed system.

Artificial Intelligence (AI) has emerged as a powerful tool in various fields of medicine, including dentistry. AI-based algorithms, particularly deep learning techniques, have shown remarkable capabilities in image analysis, pattern recognition, and decision-making. In recent years, the integration of AI technology in dentistry has opened new avenues for enhancing the accuracy and efficiency of diagnosis. AI-based algorithms may be able to recognize some features in OPG images that are imperceptible to the human eye, allowing for the detection of subtle bone loss and achieving a more accurate diagnosis of periodontal staging.

Notably, findings from our recent study revealed that a hybrid system combining AI algorithms and clinical knowledge has good performance for differentiating stage II-IV periodontitis. In the development process of this hybrid system, only clinical information provided by experienced specialists was utilized and no radiographic annotations were employed. Despite the promising potential of the hybrid system developed from our initial investigation, it is essential to further train and validate it in different independent populations because a prediction rule derived from one sample could perform better in another sample/population. Besides, it is reasonable to assume that the OPG images taken from different machines may greatly influence the accuracy of the developed hybrid system. Therefore, it is logical to conduct a multi-center study to collect different OPG images from various centers worldwide and the dataset will be utilized to train further and validate the hybrid system ensuring its accuracy and efficacy in periodontitis diagnosis.

In this study, we will compare the diagnostic characteristics of a novel AI-clinical-based hybrid system (Index test) with a panel of experts (reference standard). Experts will independently assess all radiographs and reach agreement if any discrepancy among them is found.

Being tested
AI-clincial-based hybrid system for radiographic image analysis
Keywords
Periodontitis, Artificial Intelligence, Radiograph
Medical subject headings
Periodontitis, Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-clincial-based hybrid system for radiographic image analysisDiagnostic test

    The Index test is a novel AI-clinical-based hybrid system for radiographic image analysis. Its diagnostic performance will be compared to the reference represented by a panel of experts.

Study groups in NCT06306677
Study groupRoleWhat they receive
Subjects presenting for care at HospitalsThe group is formed by subjects reporting for care at one of the four participating hospitals (China, Hong Kong SAR, Italy) who required an OPG radiographs for their routine clinical care.
Receives: Diagnostic Test: AI-clincial-based hybrid system for radiographic image analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity measure

    Sensitivity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts

    Measured: 1 day

  2. Specificity measure

    Specificity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts

    Measured: 1 day

  3. The area under the receiver operating characteristic curve (AUC) measure

    The area under the receiver operating characteristic curve (AUC) measure of AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts

    Measured: 1 day

  4. Diagnostic accuracy

    The overall diagnostic accuracy of the AI-clinical-based system will be calculated based on the fraction of true test results [Accuracy = (true positives + true negatives) / (total)] and compared with the panel of experts

    Measured: 1 day

Secondary outcomes (1)
  1. Assessment time

    Comparison of the time for diagnosis required by the AI-clinical-based hybrid system and the panel of experts for each OPG image

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start12 Mar 2024
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306677
Sponsor's protocol ID
SH9H-2023-T369-1
Status last verified
Mar 2024
First submitted
4 Mar 2024
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Cui Z, Mei L, Xie Y, Marini L, Pelekos G, Gu W, Yu X, Wu X, Wei X, Tao L, Deng K, Pilloni A, Shen D, Tonetti MS. A novel AI-powered radiographic analysis surpasses specialists in stage II-IV periodontitis detection: a multicenter diagnostic study. NPJ Digit Med. 2025 Nov 18;8(1):691. doi: 10.1038/s41746-025-02077-0.

    PubMed 41254181

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Periodontal Diseases, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 3 sites in 3 countries.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China, Hong Kong, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maurizio Tonetti (15000102368, maurizio.tonetti@ergoperio.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity measure (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306677, which also lists 1 linked publication.

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 13 Mar 2024.

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