Clinical trial NCT05153798: Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects
Official title: Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Keywords: Periodontal
Inflammation
Gingivits
PerioMonitor
Bleeding on Probing
Periodontitis
Lead sponsor: Oral Science International Inc.
Sponsor class: INDUSTRY
Collaborators: name: JSS Medical Research Inc.
First posted: 2021-12-10
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected amongst patients visiting the Sites for their scheduled regular exams, which are all outpatient dental clinics

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of PerioMonitor
timeFrame: 6 months
Secondary outcomes:
measure: Usability of PerioMonitor in Point-of-Care (POC) settings
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Lee
country: United States
facility: Fort Lee Dental Office
state: New Jersey
city: Charlotte
country: United States
facility: Robert A. Lowe Dental Office
state: North Carolina
city: Hamilton
country: Canada
facility: OMG Perio
state: Ontario
Study officials:
References: