Trials / Completed
CompletedNCT06570044
Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Oral Science International Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PerioMonitor | Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use |
Timeline
- Start date
- 2024-07-30
- Primary completion
- 2025-01-30
- Completion
- 2025-05-01
- First posted
- 2024-08-26
- Last updated
- 2025-05-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06570044. Inclusion in this directory is not an endorsement.