NCT05886855

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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2023

Last Update Submit

May 23, 2023

Conditions

Oral Inflammation

Outcome Measures

Primary Outcomes (1)

  • Bleeding on Probing (BOP)

    Confirmation of oral inflammation if BOP is equal or above 10%

    6 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals visiting a dental clinic for a regular exam.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Michel Houde, Ph.D.

CONTACT

4507811578houde.michel@lok-northamerica.com

Julie Struthers, B.Sc

CONTACT

‭(450) 442-7070‬j.struthers@oralscience.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 2, 2023

Study Start

May 24, 2023

Primary Completion

December 20, 2023

Study Completion

January 31, 2024

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share