Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.
NCT ID: NCT05886855
Last Updated: 2023-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2023-05-24
2024-01-31
Brief Summary
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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.
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Detailed Description
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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.
The primary objective of this Study is to evaluate the Positive Percent Agreement (PPA)PPA and the Negative Percent Agreement (NPA)NPA of PerioMonitor for semi-quantitative detection of neutrophil enzyme activity in human oral specimens, to detect oral inflammation associated with periodontal diseases (subjects having more than 50 000 neutrophils/mL in their oral specimen or having more than 10% of bleeding sites when tested with the BOP method).
The secondary objective is to validate the claim that PerioMonitor can be used in POC settings (i.e., representative of the intended users and under conditions similar to the conditions of use), at the time of the consultation, with instant availability of results, by healthcare professionals (HCP) working in a dental clinic (i.e. with the background, education, and training of those who will perform the test in its intended environment) that are not qualified laboratory technicians, to make immediate and informed decisions about patient care.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PerioMonitor Testing
400 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method and neutrophil count.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* subject fluent in English; and
* subject has signed the ICF
Exclusion Criteria
* Subject using immunosuppressants including biologics such as adalimumab (Humira) and infliximab (Remicade); or calcineurin inhibitors such as tacrolimus (Envarsus XR or Protopic) and cyclosporine (Gengraf, Neotal or Sandimmmune); or corticosteroids (Prednisone); or azathioprine (Imuran)
* Oral rinse specimens received 5 days or more after PerioMonitor testing by the clinical laboratory
* Previous enrolment into the current Study.
18 Years
ALL
No
Sponsors
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Advarra
INDUSTRY
Oral Science International Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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230123-01
Identifier Type: -
Identifier Source: org_study_id
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