CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 408 enrolled
Drug / intervention
Bleeding on brushingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03928080
NCT03928080N/ACompleted

Self-detection and Professional Screening Strategies for Early Detection of Periodontitis: Diagnostic Accuracy of Bleeding on Brushing, Salivary Activated Matrix Metalloproteinase-8 (aMMP-8) and CDC/AAP Screening Questionnaire

The European Research Group on Periodontology (ERGOPerio)·observational·Posted Apr 25, 2019·Updated Jan 11, 2022

In Brief

An observational study evaluating Bleeding on brushing for Periodontitis and Gingivitis. Completed, enrolled 408 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 25, 2019
Enrollment StartSep 1, 2019
Primary CompletionJun 30, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.2 years ago

Interventions

Bleeding on brushingother

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