Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects
- Conditions
- Periodontal Diseases
- Registration Number
- NCT05153798
- Lead Sponsor
- Oral Science International Inc.
- Brief 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.
- Detailed Description
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:
1. studies to evaluate the sensitivity and the specificity of the device to provide clinically meaningful results in the target population; and
2. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 117
- subject > 18 years old;
- subject fluent in English; and
- subject has signed an ICF.
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- Previous enrolment into the current Study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of PerioMonitor 6 months 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.
- Secondary Outcome Measures
Name Time Method Usability of PerioMonitor in Point-of-Care (POC) settings 6 months 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.
Trial Locations
- Locations (3)
Robert A. Lowe Dental Office
🇺🇸Charlotte, North Carolina, United States
Fort Lee Dental Office
🇺🇸Fort Lee, New Jersey, United States
OMG Perio
🇨🇦Hamilton, Ontario, Canada