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.
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
- Recruiting
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, 201206
Yuan Li, 13916337473, ly9919@hotmail.com
Hong Kong1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospital
Hong Kong
George Pelekos, george74@hku.hk
Italy1 site, 1 recruiting
- Recruiting
La Sapienza Dental School
Roma
Lorenzo Marini, lorenzo.marini@uniroma1.it
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.
- Conditions
- Periodontitis, Periodontal Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Subjects presenting for care at Hospitals | The 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.
Sensitivity measure
Sensitivity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts
Measured: 1 day
Specificity measure
Specificity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts
Measured: 1 day
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
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)
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.
- First posted12 Mar 2024
- Study start12 Mar 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ShanghaiTech University, University of Roma La Sapienza, The University of Hong Kong
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Maurizio Tonetti, Principal investigator, Shanghai Ninth People Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06306677
- Acronym / sponsor ID
- SH9H-2023-T369-1
- Conditions
- Periodontitis, Periodontal Diseases
- Keywords
- Periodontitis, Artificial Intelligence, Radiograph
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- ShanghaiTech University, University of Roma La Sapienza, The University of Hong Kong
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Mar 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects presenting for care at Hospitals | – | Diagnostic Test: AI-clincial-based hybrid system for radiographic image analysisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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;
Key inclusion criteria (2 listed)
- Aged 18 and above
- Having taken the OPG image
Key exclusion criteria (1 listed)
- Edentulous mouth
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 |
|---|---|---|
| AI-clincial-based hybrid system for radiographic image analysisThe 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. | Diagnostic test | Subjects presenting for care at Hospitals |
Primary outcome
Sensitivity measure
Time frame: 1 day
Sensitivity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts
Specificity measure
Time frame: 1 day
Specificity of the AI-clinical based hybrid system to correctly identify periodontitis cases labeled by panel of experts
The area under the receiver operating characteristic curve (AUC) measure
Time frame: 1 day
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
Diagnostic accuracy
Time frame: 1 day
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
1 secondary outcome
Assessment time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 41254181Li 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maurizio Tonetti principal investigator
Shanghai Ninth People Hospital
3 sites in 3 countries: see every site and its status.
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.