NCT03928080

Diagnostic Accuracy of Rapid Non-clinical Screening Tests for Early Detection of Periodontitis

Completed Last updated 11 January 2022

What this trial tests

trial testing Bleeding on brushing in Periodontitis in 408 participants. Completed in 31 December 2020.

Timeline

1 September 2019

Primary endpoint
30 June 2020

31 December 2020

Quick facts

Lead sponsor	The European Research Group on Periodontology (ERGOPerio)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	408
Start date	1 September 2019
Primary completion	30 June 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• Bleeding on brushing

Conditions studied

• Periodontitis — all drugs for Periodontitis →
• Gingivitis — all drugs for Gingivitis →

Sponsor

The European Research Group on Periodontology (ERGOPerio)

Who can join

18 and older, any sex, with Periodontitis or Gingivitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gum disease is the 6th most prevalent disease of mankind. It is a non-communicable non-resolving inflammation; if untreated it leads to tooth loss and inability to chew properly. It is one of the top 80 human disease contributing 3.5 million years lived with disability and the major cause of increasing oral health costs. Addressing this major public health problem requires greater attention to prevention and early detection.

Gum disease cases in the population remain largely undetected because an affected individual does not feel the presence of gum disease and as a consequence people seek attention in the later stages of the disease once tooth loss has occurred.

In this study the investigators will compare different methods of screening for gum disease and compare them against a full professional examination. The investigators hope to be able to propose simple and effective methods for self-assessment that will allow people to suspect the presence of the disease before tooth loss occurs and thus allow early diagnosis and better treatment.

The whole study procedures consist 3 screening tests and the standard clinical examination. The screening tests involves:(1) a screening questionnaire; (2) a saliva test; (3) a toothbrushing test. Thereafter the participants will receive a standard clinical examination which is regarded as the gold standard for diagnosis of gum disease. Results of these tests will be compared with the standard clinical examination to assess the diagnostic accuracy of these tests.

The general aim of this program is to improve early detection of periodontitis in the population using a self-detection approach based on a toothbrush test as an early sign and a self-performed saliva test as a screening test for an individual to seek professional dental care early in the gum disease process.

The general hypothesis is that combining self-assessment of toothbrush test with a saliva test as an assessment of key inflammatory process underlying gum disease will increase the diagnostic accuracy of a screening approach in the population.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Diagnostic accuracy of a point-of-care aMMP-8 test in the discrimination of periodontal health and disease.
   Deng K, Pelekos G, Jin L, Tonetti MS. · · 2021 · cited 62× · PMID 33998040 · DOI 10.1111/jcpe.13485
2. Food intake, masticatory function, tooth mobility, loss of posterior support, and diminished quality of life are associated with more advanced periodontitis stage diagnosis.
   Uy SNMR, Deng K, Fok CTC, Fok MR, et al · · 2022 · cited 56× · PMID 34935175 · DOI 10.1111/jcpe.13588
3. Development of a machine learning multiclass screening tool for periodontal health status based on non-clinical parameters and salivary biomarkers.
   Deng K, Zonta F, Yang H, Pelekos G, et al · · 2024 · cited 27× · PMID 37697491 · DOI 10.1111/jcpe.13856
4. Gingival bleeding on brushing as a sentinel sign of gingival inflammation: A diagnostic accuracy trial for the discrimination of periodontal health and disease.
   Deng K, Pelekos G, Jin L, Tonetti MS. · · 2021 · cited 26× · PMID 34494292 · DOI 10.1111/jcpe.13545
5. Diagnostic Accuracy of a Point-Of-Care aMMP-8 Test for Discriminating Periodontal Health Status in Adults: Validation Trials and Updated Meta-Analysis.
   Li Y, Kung JCK, Shi J, Wu X, et al · · 2025 · cited 8× · PMID 39806539 · DOI 10.1111/jcpe.14119
6. Clinical Features Associated With Periodontal Case Misclassification by an Active Matrix Metalloproteinase-8 Point-of-Care Oral Rinse Test.
   Bi M, Xie Y, Yu X, Li H, et al · · 2025 · cited 3× · PMID 40462486 · DOI 10.1111/jcpe.14189