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

Last updated: May 20, 2025
Sponsor: Oral Science International Inc.
Overall Status: Completed

Phase

N/A

Condition

Canker Sores

Inflammation

Treatment

PerioMonitor

Clinical Study ID

NCT06570044
20240513
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • subject fluent in English

  • subject has signed the ICF

Exclusion

Exclusion Criteria:

  • subject with altered mental status/inability to provide informed consent or followthe procedure of the Study

  • Previous enrolment into the current Study

  • Patients with known severe oral diseases such as oral cancer

Study Design

Total Participants: 86
Treatment Group(s): 1
Primary Treatment: PerioMonitor
Phase:
Study Start date:
July 30, 2024
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • 1st Family Medicine

    Buckeye, Arizona 85326
    United States

    Site Not Available

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