Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice

Completed · Not applicable

Conditions studied: Oral Inflammation

In brief

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).

Key facts

Study ID

NCT06570044

Run by

Oral Science International Inc.

People needed

86

Starts

2024-07-30

Expected to finish

2025-05-01

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• subject fluent in English
• subject has signed the ICF

You may not qualify if…

• subject with altered mental status/inability to provide informed consent or follow the procedure of the Study
• Previous enrolment into the current Study
• Patients with known severe oral diseases such as oral cancer

Where it is running

• 1st Family Medicine — Buckeye, Arizona, United States

Full record on ClinicalTrials.gov

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