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

May 23, 2023 updated by: Oral Science International Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Individuals visiting a dental clinic for a regular exam.

Description

Inclusion Criteria:

  • subject > 18 years old;
  • subject fluent in English; and
  • subject has signed the ICF

Exclusion Criteria:

  • Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on Probing (BOP)
Time Frame: 6 months
Confirmation of oral inflammation if BOP is equal or above 10%
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oral Science International Inc.

Collaborators

Advarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 24, 2023

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Estimated)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230123-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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