Self-detection and Professional Screening Strategies for Early Detection of Periodontal Disease

NCT ID: NCT05513599

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-01

Brief 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. 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.

Conditions

Periodontitis; Diagnosis; Self-Assessment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Aged 18 and above
• Ability and willingness to give written informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Tonetti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Perio-Implant Innovation Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Maurizio TOnetti, DMD

Role: CONTACT

maurizio.tonetti@ergoperio.eu

15000102368

Facility Contacts

Jojo Qian, PhD

Role: primary

qianshujiao@gmail.com

References

Bi 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.

Reference Type: DERIVED

PMID: 40462486 (View on PubMed)

Other Identifiers

diagnostic2022

Identifier Type: -

Identifier Source: org_study_id