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

NCT06570044 | Completed FDA Device

• 1 other identifier: 20240513
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Oral Inflammation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Proportion (%) of participants referred to a Dental Specialist

  6-Month

• Proportion (%) participants referred to a Dental Specialist

  12-Month

• Proportion (%) of compliant participants with the recommended visit to a Dental Specialist

  6-Month

• Proportion (%) of compliant participants with the recommended visit to a Dental Specialist

  12-Month

Study Arms (1)

PerioMonitor

EXPERIMENTAL

Diagnostic Test: PerioMonitor

Interventions

PerioMonitor DIAGNOSTIC_TEST

Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use

PerioMonitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Oral Science International Inc.: lead

Study Sites (1)

1st Family Medicine

Buckeye, Arizona, 85326, United States

Location

Study Officials

• Samuel B Low

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: July 30, 2024
• Primary Completion: January 30, 2025
• Study Completion: May 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)