Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.
NCT05886855 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2023-06-02
Summary
The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.
PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.
Conditions
- Oral Inflammation
Sponsors & Collaborators
-
Advarra
collaborator INDUSTRY -
Oral Science International Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-24
- Primary Completion
- 2023-12-20
- Completion
- 2024-01-31
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