Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
NCT ID: NCT06570044
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2024-07-30
2025-05-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PerioMonitor
PerioMonitor
Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use
Interventions
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PerioMonitor
Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use
Eligibility Criteria
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Inclusion Criteria
* subject has signed the ICF
Exclusion Criteria
* Previous enrolment into the current Study
* Patients with known severe oral diseases such as oral cancer
18 Years
ALL
Yes
Sponsors
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Oral Science International Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel B Low
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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1st Family Medicine
Buckeye, Arizona, United States
Countries
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Other Identifiers
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20240513
Identifier Type: -
Identifier Source: org_study_id
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