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

NCT03928080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 408

Last updated 2022-01-11

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis
  • Gingivitis

Interventions

DIAGNOSTIC_TEST

Bleeding on brushing

Index tests are bleeding on brushing and aMMP-8 Gold standard: clinical diagnosis performed by specialist

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • The European Research Group on Periodontology (ERGOPerio)

    lead NETWORK

Principal Investigators

  • Maurizio Tonetti, DMD,PhD,MMSc · The University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928080 on ClinicalTrials.gov