MedPath

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

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
NameTimeMethod
Comfort to participantsDay 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 errorDay 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 testsDay 0

The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed

Ease of Test PerformanceDay 0

The Ease-of-Test Performance will be evaluated by a 5-question questionnaire

Secondary Outcome Measures
NameTimeMethod
Proportion (%) participants referred to a Dental Specialist12-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 Specialist6-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 Specialist12-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

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

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