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

Study Overview
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Brief Summary
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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.

Detailed Description
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PerioMonitor is an IVD device for the rapid, semi-quantitative detection of PMN in oral samples. This test is intended for prescription use at POC settings by health care professionals. This type of In vitro diagnostic device (IVDD) is also sometimes defined as a Near-Patient Testing IVDD. Conducting investigational testing is a pre-requisite to obtain a Class III medical device licence in respect to in vitro diagnostic devices intended for use in POC settings (e.g., home use or outpatient dental clinic) from Health Canada. Such studies are mandatory to establish the safety and effectiveness of the device should be presented to support the performance for each claimed indication for use. They must be conducted on the device using human subjects representative of the intended users and under conditions similar to the conditions of use, to provide reasonable assurance of safety and effectiveness for the intended use. This notably includes: studies to evaluate the sensitivity and the specificity of the device to provide clinically meaningful results in the target population; and consumer fields evaluations, i.e., studies evaluating the performance of the device when used by the intended users without assistance, following instructions provided in the labelling. The same is also applicable in the United States of America. More specifically with respect to consumer field evaluations, FDA requires clinical data to determine whether particular tests are simple and have an insignificant risk of an erroneous result to be approved for waiver under the CLIA criteria and cleared for use in POC settings. This document is a clinical investigational plan specifically designed for the conduct of a blinded, multicenter and prospective, single arm human Study to evaluate the safety and the efficacy of PerioMonitor as an aid to the presumptive detection of oral inflammation associated with periodontal diseases. This single-arm Study is designed to be representative of the intended use of PerioMonitor as well as the intended users, intended patient population and intended environment of use. To this end, the Study will include a minimum of 117 subjects, tested by HCPs working in three different dental clinics (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, with PerioMonitor.

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

Conditions
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Periodontal Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject > 18 years old; subject fluent in English; and subject has signed an ICF. Exclusion Criteria: Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and Previous enrolment into the current Study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PerioMonitor Testing<br>117 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of PerioMonitor | The primary objective of this blinded, multicenter and prospective Study is to evaluate the sensitivity and the specificity of PerioMonitor for semi-quantitative detection of PMN in human oral specimens, which may improve the detection of oral inflammation associated with periodontal diseases. Based on our preliminary results, a sensitivity of 90% (95CI 80.0-100%) and a specificity of 75% (65.1-100%) are expected when testing a cohort of 117 subjects. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of PerioMonitor in Point-of-Care (POC) settings | 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 HCPs 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, with a negligible likelihood of erroneous results. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Periodontal, Inflammation, Gingivits, PerioMonitor, Bleeding on Probing