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Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects

NCT05153798 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2021-12-10

No results posted yet for this study

Summary

The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases.

PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.

Conditions

  • Periodontal Diseases

Sponsors & Collaborators

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Oral Science International Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153798 on ClinicalTrials.gov