Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects
1 other identifier
observational
117
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2021
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedDecember 10, 2021
November 1, 2021
2 months
December 8, 2021
December 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Usability of PerioMonitor in Point-of-Care (POC) settings
6 months
Study Arms (1)
PerioMonitor Testing
117 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method.
Eligibility Criteria
Subjects will be selected amongst patients visiting the Sites for their scheduled regular exams, which are all outpatient dental clinics
You may qualify if:
- subject \> 18 years old;
- subject fluent in English; and
- subject has signed an ICF.
You may not qualify if:
- Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
- Previous enrolment into the current Study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oral Science International Inc.lead
- JSS Medical Research Inc.collaborator
Study Sites (3)
Fort Lee Dental Office
Fort Lee, New Jersey, 07024, United States
Robert A. Lowe Dental Office
Charlotte, North Carolina, 28226, United States
OMG Perio
Hamilton, Ontario, L8N 1K4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
December 10, 2021
Study Start
November 29, 2021
Primary Completion
January 31, 2022
Study Completion
January 31, 2022
Last Updated
December 10, 2021
Record last verified: 2021-11