Expired Study
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Lexington, Kentucky 40506


Purpose:

The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.


Study summary:

Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels. Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.


Criteria:

Inclusion Criteria: - Males or females of all racial and ethnic groups over 18 years of age; - At least 20 erupted teeth and the ability to provide expectorated saliva; - Able and willing to comply with study requirements; and - Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures Exclusion Criteria: - Prisoners or institutionalized individuals; - Persons with acute illness or infectious disease (as evidenced by fever, malaise, sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician consultation); - Evidence of oral mucosal lesion or ulceration; or - Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen, Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two weeks.


NCT ID:

NCT02403297


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40506
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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