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

Not Applicable

Completed

• Conditions: Oral Inflammation

• Registration Number: NCT06570044
• Lead Sponsor: Oral Science International Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Primary Completion: 2025-01-30
• Status Verified: 2025-05
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comfort to participants	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.
Use error	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
Ratio (%) of valid tests/performed tests	Day 0	The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed
Ease of Test Performance	Day 0	The Ease-of-Test Performance will be evaluated by a 5-question questionnaire

Secondary Outcome Measures

Name	Time	Method
Proportion (%) participants referred to a Dental Specialist	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.
Proportion (%) of participants referred to a Dental Specialist	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.
Proportion (%) of compliant participants with the recommended visit to a Dental Specialist	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.

Trial Locations

Locations (1)

1st Family Medicine; 🇺🇸 Buckeye, Arizona, United States