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

Oral Science International

Status: Completed

Conditions: Oral Inflammation

Treatments: Diagnostic Test: PerioMonitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06570044

20240513

Details and patient eligibility

About

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).

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

PerioMonitor

Experimental group

Treatment:

Diagnostic Test: PerioMonitor