Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Conditions
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Gingivitis, Periodontal Disease

Intervention / Treatment
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* Device: Quik Check PD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Saliva will be collected from 58 subjects determined to be healthy according to the protocol. | Device: Quik Check PD<br>* The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.<br>|
| Gingivitis<br>Saliva will be collected from 58 subjects determined to have gingivitis according to the protocol. | Device: Quik Check PD<br>* The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.<br>|
| Periodontal disease<br>Saliva will be collected from 58 subjects determined to have periodontal disease according to the protocol. | Device: Quik Check PD<br>* The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of MMP-8 in the subjects saliva using the Quik Check PD device |  | One day. Subjects complete the study in 45 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of MMP-8 in the subjects saliva sample using Luminex Analysis |  | One day. Subjects complete the study in 45 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding gums, Gum inflammation, Saliva