Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
NCT Number: NCT06570044
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Inflammation
Interventions: DIAGNOSTIC_TEST: PerioMonitor
Sponsor: Oral Science International Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-30
Completion Date: 2025-07-30
Locations: 1st Family Medicine, Buckeye, Arizona, 85326, United States

Summary:
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).

Primary Outcome Measures: 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
Secondary Outcome Measures: 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|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