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OpenTrials
Completed

NCT Number: NCT06570044

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

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).

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Key information

Conditions

Oral Inflammation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1st Family Medicine

Buckeye, Arizona, 85326, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PerioMonitor

Diagnostic Test

Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use

Primary outcomes

  1. Ratio (%) of valid tests/performed tests

    Time frame: Day 0

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

  2. Ease of Test Performance

    Time frame: Day 0

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

  3. Use error

    Time frame: 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

  4. Comfort to participants

    Time frame: 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.

Secondary outcomes

  1. Proportion (%) of participants referred to a Dental Specialist

    Time frame: 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.

  2. Proportion (%) participants referred to a Dental Specialist

    Time frame: 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.

  3. Proportion (%) of compliant participants with the recommended visit to a Dental Specialist

    Time frame: 6-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.

  4. Proportion (%) of compliant participants with the recommended visit to a Dental Specialist

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oral Science International Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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