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

NCT05513599 | Unknown

• 1 other identifier: diagnostic2022
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diagnosis; Self-Assessment

Keywords

Periodontitis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting untreated patients seeking care at Shanghai Perioimplant Innovation Centre of Shanghai Ninth People's Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Perio-Implant Innovation Center

Shanghai, Shanghai Municipality, 201206, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 41254181 DERIVED

• 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.

  PMID: 40462486 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. unstimulated whole saliva sample 2. mouth rinsing sample 3. subgingival plaque sample 4. plasma and whole blood specimens

MeSH Terms

Conditions

Periodontitis; Disease

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maurizio TOnetti, DMD

CONTACT

15000102368; maurizio.tonetti@ergoperio.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 24, 2022
• Study Start: August 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: April 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

CN (1)