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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-05-01

Brief Summary

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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

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Conditions

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Oral Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PerioMonitor

Group Type EXPERIMENTAL

PerioMonitor

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oral Science International Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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20240513

Identifier Type: -

Identifier Source: org_study_id

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