Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03928080
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Maurizio Tonetti, The University of Hong Kong

Brief 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.


Condition or disease Intervention/treatment
Periodontitis Gingivitis Diagnostic Test: Bleeding on brushing

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Experimental cohort
Primary study to assess diagnostic accuracy
Diagnostic Test: Bleeding on brushing
Index tests are bleeding on brushing and aMMP-8 Gold standard: clinical diagnosis performed by specialist
Other Name: aMMP-8

Confirmation cohort
Second cohort to confirm results from the first study on independent population
Diagnostic Test: Bleeding on brushing
Index tests are bleeding on brushing and aMMP-8 Gold standard: clinical diagnosis performed by specialist
Other Name: aMMP-8




Primary Outcome Measures :
  1. Sensitivity measure [ Time Frame: 1day ]
    Sensitivity of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  2. Specificity measure [ Time Frame: 1day ]
    Specificity of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  3. The area under the receiver operating characteristic curve (AUC) measure [ Time Frame: 1day ]
    The area under the receiver operating characteristic curve (AUC) of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination

  4. The post-test probability measure [ Time Frame: 1day ]
    The post-test probability of BoB, aMMP-8 and CDC/AAP screening questionnaires alone and in combination to correctly identify periodontitis cases at the time of completion of clinical examination


Biospecimen Retention:   Samples Without DNA
Saliva and mouth rinse


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
a convenience sample of consecutive untreated subjects seeking dental care at Prince Philip Dental Hospital
Criteria

Inclusion Criteria:

  • Aged 18 and above.
  • Having the ability to learn the standard toothbrushing method with artificial intelligence powered toothbrush.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928080


Contacts
Layout table for location contacts
Contact: Maurizio Tonetti, DMD,PhD +852 2859 0297 tonetti@hku.hk

Locations
Layout table for location information
China
Prince Philip Dental Hospital, the Univerisity of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Maurizio Tonetti, DMD,PhD    +852 2859 0297    tonetti@hku.hk   
Contact: Ke Deng, PhD    +852 9538 7871    coraldeng@hku.hk   
Principal Investigator: Maurizio Tonetti, DMD, PhD         
Sponsors and Collaborators
The European Research Group on Periodontology (ERGOPerio)
The University of Hong Kong
Investigators
Layout table for investigator information
Principal Investigator: Maurizio Tonetti, DMD,PhD,MMSc The University of Hong Kong

Publications of Results:

Layout table for additonal information
Responsible Party: Maurizio Tonetti, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03928080     History of Changes
Other Study ID Numbers: PhD20190130
HKUCTR-2631 ( Registry Identifier: HKU Clinical Trial Registry )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maurizio Tonetti, The University of Hong Kong:
diagnostic accuracy
early detection
self-assessment
periodontitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases