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The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation.
PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PerioMonitor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PerioMonitor | Diagnostic Test | Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio (%) of valid tests/performed tests | The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed | Day 0 |
| Ease of Test Performance | The Ease-of-Test Performance will be evaluated by a 5-question questionnaire | Day 0 |
| Use error | Any issue encountered with collection of specimens and/or test reading. The overall ratio (%) of tests with use errors as well as the ratio per operator will be measured | Day 0 |
| Comfort to participants | Comfort to participants with sample collection (Yes/No). The Overall ratio (%) of discomfort ('No') as well as the ratio per operator will be measured. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of participants referred to a Dental Specialist | The recommended course of action further to completion of the PerioMonitor test will be documented with a 4-item report form. The ratio (%) of participants referred to a dental specialist visit as the recommended course of action will be calculated. | 6-Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel B Low | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Family Medicine | Buckeye | Arizona | 85326 | United States |
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| Proportion (%) participants referred to a Dental Specialist |
The recommended course of action further to completion of the PerioMonitor test will be documented with a 4-item report form. The ratio (%) of participants referred to a dental specialist visit as the recommended course of action will be calculated. |
| 12-Month |
| Proportion (%) of compliant participants with the recommended visit to a Dental Specialist | Visits to a Dental Specialist will be monitored by querying participants' electronic medical records or by direct contact (email or phone) and data (visit date, treatment) will be documented in a report form. The ratio (%) of participants who completed a visit to a Dental Specialist over all participants referred to a dental specialist visit as the recommended course of action will be calculated. | 6-Month |
| Proportion (%) of compliant participants with the recommended visit to a Dental Specialist | Visits to a Dental Specialist will be monitored by querying participants' electronic medical records or by direct contact (email or phone) and data (visit date, treatment) will be documented in a report form. The ratio (%) of participants who completed a visit to a Dental Specialist over all participants referred to a dental specialist visit as the recommended course of action will be calculated. | 12-Month |