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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Saliva will be collected from 58 subjects determined to be "healthy" according to the protocol. |
| |
| Gingivitis | Saliva will be collected from 58 subjects determined to have gingivitis according to the protocol. |
| |
| Periodontal disease | Saliva will be collected from 58 subjects determined to have periodontal disease according to the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quik Check PD | Device | The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Diagnostics Inc | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D010510 | Periodontal Diseases |
| D005884 | Gingival Hemorrhage |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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5ml of saliva will be collected. A small sample of the saliva will be used chair side to analyze on the device. The remaining saliva will be aliquoted into five samples and kept frozen until analyzed on a Luminex machine.
| D006472 |
| Oral Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |