PeriodontitisNCT05513599
Self-detection and Professional Screening Strategies for Early Detection of Periodontal Disease
An observational study of Periodontitis and Diagnosis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The majority of the burden of periodontal diseases in the population remain undetected. Self-detection and confirmation with simple, non-clinical tests may improve early case detection 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, Diagnosis, Self-Assessment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Apr 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: Consenting untreated patients seeking care at Shanghai Perioimplant Innovation Centre of Shanghai Ninth People's Hospital
Who may be able to join
- Aged 18 and above
- Ability and willingness to give written informed consent
Who cannot join
- Edentulous mouth
- Pregnant females
- Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
- Having received antibiotic medication within the previous 3 months
- Presence of bleeding disorders interfering with blood draw
- Presence of xerostomia interfering with saliva sampling
- Inability or unwillingness of individual to give written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, 201206
Jojo Qian, PhD, qianshujiao@gmail.com
About this study
Official title: Diagnostic Accuracy of Self-Reported Parameters, Oral and Systemic Biomarker Profile for the Detection of Periodontal Health and Disease
The majority of the burden of periodontal diseases in the population remain undetected. Self-detection and confirmation with simple, non-clinical tests may improve early case detection and access to the needed level of care. A recently conducted study has indicated that self-reported signs and symptoms through questionnaires and gingival bleeding on brushing (GBoB), in particular, are potentially useful approaches to detect gingival inflammation and other signs of periodontal health and disease. A parallel study evaluated the accuracy of the presence of elevated levels of activated matrix metalloproteinase-8 (MMP-8). A strategy combining specific questions, subject demographics, GBoB and aMMP-8 has shown promise for screening and diagnosis of periodontal health and disease. Validation of a diagnostic approach requires assessment in a first population (development group) and confirmation in an independent one.
Read the detailed description
Periodontal disease (mostly plaque-induced gingivitis and periodontitis) is probably the most prevalent non-communicable diseases of mankind, with substantial socio-economic impacts and considerable effects on individuals' oral health and general health/well-being (Jin et al., 2016; Listl et al., 2015; Tonetti et al., 2017). Currently, periodontal disease in the population remains largely undetected. It is therefore of great importance to enhance the awareness of periodontal health and improve the early diagnosis of periodontal disease for effective care.
Although the clinical examinations are considered the gold standard for the diagnosis, there are several sets of limitations, such as its laborious and time-consuming process that requires highly skilled dental practitioners, the lack of adequate precision for the detection of incipient periodontitis, and the insufficiency of reflecting ongoing disease activity/risk of progression events. Consequently, alternative cost-effective but reliable and valid approaches for periodontal screening/diagnosis particularly in public communities are highly needed.
Self-detection and confirmation with simple, non-clinical tests may improve early case detection and access to the needed level of care. The recent findings from our group have indicated that self-reported signs and symptoms through questionnaires and toothbrushing testing for Gingival Bleeding on brushing (GBoB), are potentially useful approaches to detect gingival inflammation and other signs of periodontal health and disease (Deng et al., 2021a; Tonetti et al., 2020). Moreover, oral biomarkers can give an indication of the probable disease status and allow monitoring of the biochemical processes associated with periodontal disease. A parallel study that evaluated the diagnostic utility of a point-of-care test for the activated matrix metalloproteinase-8 (aMMP-8), a biomarker associated with the collagen degradation of periodontium in periodontitis, has shown a significant association but limited accuracy for periodontitis (Deng et al., 2021b). In addition, increasing evidence suggests that the local inflammatory and/or infectious burden might trigger a systemic host response and alter the individual metabolic status. It is therefore logical to employ metabolic and inflammatory markers for estimating the risk of systemic inflammatory burden of periodontitis and to assess their relationship with the grading and staging of periodontitis based on the 2017 classification.
Notably, findings from our recent study revealed that a strategy combining specific questions, subject demographics, GBoB and aMMP-8 has good performance for differentiating periodontal health, gingivitis and periodontitis (unpublished). Despite a promising potential of the screening/diagnostic models developed from our initial investigation, it is essential to externally validate them in an independent population because a prediction rule derived from one sample does not necessarily perform well in a different sample/population.
- Conditions
- Periodontitis, Diagnosis, Self-Assessment
- Keywords
- Periodontitis
- Medical subject headings
- Periodontitis, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity measure
Sensitivity of self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
Measured: 1 day
Specificity measure
Specificity of self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
Measured: 1 day
The area under the receiver operating characteristic curve (AUC) measure
The area under the receiver operating characteristic curve (AUC) measure of self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
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 posted24 Aug 2022
- Study start1 Aug 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513599
- Sponsor's protocol ID
- diagnostic2022
- Status last verified
- Sep 2023
- First submitted
- 23 Aug 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 41254181Tao LR, Li Y, Wu XY, Gu Y, Xie Y, Yu XY, Lai HC, Tonetti MS. Deep Learning Photo Processing for Periodontitis Screening. J Dent Res. 2026 Feb;105(2):226-235. doi: 10.1177/00220345251347508. Epub 2025 Jul 12.
PubMed 40650464Bi M, Xie Y, Yu X, Li H, Pelekos G, Jin L, Li Y, Tonetti MS. Clinical Features Associated With Periodontal Case Misclassification by an Active Matrix Metalloproteinase-8 Point-of-Care Oral Rinse Test. J Clin Periodontol. 2025 Sep;52(9):1276-1287. doi: 10.1111/jcpe.14189. Epub 2025 Jun 3.
PubMed 40462486
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Self-Reported Parameters, Oral and Systemic Biomarker Profile for the Detection of Periodontal Health and Disease
- ClinicalTrials.gov ID
- NCT05513599
- Acronym / sponsor ID
- diagnostic2022
- Conditions
- Periodontitis, Diagnosis, Self-Assessment
- Keywords
- Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 24 Aug 2022 (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.
The majority of the burden of periodontal diseases in the population remain undetected. Self-detection and confirmation with simple, non-clinical tests may improve early case detection and access to the needed level of care. A recently conducted study has indicated that self-reported signs and symptoms through questionnaires and gingival bleeding on brushing (GBoB), in particular, are potentially useful approaches to detect gingival inflammation and other signs of periodontal health and disease. A parallel study evaluated the accuracy of the presence of elevated levels of activated matrix metalloproteinase-8 (MMP-8). A strategy combining specific questions, subject demographics, GBoB and aMMP-8 has shown promise for screening and diagnosis of periodontal health and disease. Validation of a diagnostic approach requires assessment in a first population (development group) and confirmation in an independent one.
Detailed description
Periodontal disease (mostly plaque-induced gingivitis and periodontitis) is probably the most prevalent non-communicable diseases of mankind, with substantial socio-economic impacts and considerable effects on individuals' oral health and general health/well-being (Jin et al., 2016; Listl et al., 2015; Tonetti et al., 2017). Currently, periodontal disease in the population remains largely undetected. It is therefore of great importance to enhance the awareness of periodontal health and improve the early diagnosis of periodontal disease for effective care.
Although the clinical examinations are considered the gold standard for the diagnosis, there are several sets of limitations, such as its laborious and time-consuming process that requires highly skilled dental practitioners, the lack of adequate precision for the detection of incipient periodontitis, and the insufficiency of reflecting ongoing disease activity/risk of progression events. Consequently, alternative cost-effective but reliable and valid approaches for periodontal screening/diagnosis particularly in public communities are highly needed.
Self-detection and confirmation with simple, non-clinical tests may improve early case detection and access to the needed level of care. The recent findings from our group have indicated that self-reported signs and symptoms through questionnaires and toothbrushing testing for Gingival Bleeding on brushing (GBoB), are potentially useful approaches to detect gingival inflammation and other signs of periodontal health and disease (Deng et al., 2021a; Tonetti et al., 2020). Moreover, oral biomarkers can give an indication of the probable disease status and allow monitoring of the biochemical processes associated with periodontal disease. A parallel study that evaluated the diagnostic utility of a point-of-care test for the activated matrix metalloproteinase-8 (aMMP-8), a biomarker associated with the collagen degradation of periodontium in periodontitis, has shown a significant association but limited accuracy for periodontitis (Deng et al., 2021b). In addition, increasing evidence suggests that the local inflammatory and/or infectious burden might trigger a systemic host response and alter the individual metabolic status. It is therefore logical to employ metabolic and inflammatory markers for estimating the risk of systemic inflammatory burden of periodontitis and to assess their relationship with the grading and staging of periodontitis based on the 2017 classification.
Notably, findings from our recent study revealed that a strategy combining specific questions, subject demographics, GBoB and aMMP-8 has good performance for differentiating periodontal health, gingivitis and periodontitis (unpublished). Despite a promising potential of the screening/diagnostic models developed from our initial investigation, it is essential to externally validate them in an independent population because a prediction rule derived from one sample does not necessarily perform well in a different sample/population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting untreated patients seeking care at Shanghai Perioimplant Innovation Centre of Shanghai Ninth People's Hospital
Key inclusion criteria (2 listed)
- Aged 18 and above
- Ability and willingness to give written informed consent
Key exclusion criteria (7 listed)
- Edentulous mouth
- Pregnant females
- Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
- Having received antibiotic medication within the previous 3 months
- Presence of bleeding disorders interfering with blood draw
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 measure
Time frame: 1 day
Sensitivity of self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
Specificity measure
Time frame: 1 day
Specificity of self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
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 self-reported measures, oral and systemic biomarkers alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- 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.
- Derived from this study: PubMed 40650464Tao LR, Li Y, Wu XY, Gu Y, Xie Y, Yu XY, Lai HC, Tonetti MS. Deep Learning Photo Processing for Periodontitis Screening. J Dent Res. 2026 Feb;105(2):226-235. doi: 10.1177/00220345251347508. Epub 2025 Jul 12.
- Derived from this study: PubMed 40462486Bi M, Xie Y, Yu X, Li H, Pelekos G, Jin L, Li Y, Tonetti MS. Clinical Features Associated With Periodontal Case Misclassification by an Active Matrix Metalloproteinase-8 Point-of-Care Oral Rinse Test. J Clin Periodontol. 2025 Sep;52(9):1276-1287. doi: 10.1111/jcpe.14189. Epub 2025 Jun 3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Diagnosis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 7 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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, DMD (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 3 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 NCT05513599, which also lists 3 linked publications.
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 7 Sep 2023.