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

May 20, 2025 updated by: Oral Science International Inc.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Buckeye, Arizona, United States, 85326
        • 1st Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • subject fluent in English
  • subject has signed the ICF

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PerioMonitor
Diagnostic test: PerioMonitor
Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio (%) of valid tests/performed tests
Time Frame: Day 0
The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed
Day 0
Ease of Test Performance
Time Frame: Day 0
The Ease-of-Test Performance will be evaluated by a 5-question questionnaire
Day 0
Use error
Time Frame: Day 0
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
Time Frame: Day 0
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

Outcome Measure
Measure Description
Time Frame
Proportion (%) of participants referred to a Dental Specialist
Time Frame: 6-Month
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
Time Frame: 12-Month
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
Time Frame: 6-Month

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
Time Frame: 12-Month

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oral Science International Inc.

Investigators

  • Principal Investigator: Samuel B Low, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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