NCT05153798|Unknown
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Sponsor study identifier
observational
117
2 countries
3
Study Start
November 29, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 8, 2021
Actual (reported)December 10, 2021
Actual (reported)January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Usability of PerioMonitor in Point-of-Care (POC) settings
6 months
117 Subject to be tested for Oral Inflammatory Load (OIL) with PerioMonitor. Same subjects to be tested for Oral Inflammation with the BOP method.
Subjects will be selected amongst patients visiting the Sites for their scheduled regular exams, which are all outpatient dental clinics
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
First Submitted
December 8, 2021
First Posted
December 10, 2021
Study Start
November 29, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 31, 2022
Estimated (date passed)Evaluation of Salivary Biomarker Levels of Individuals With Different Periodontal Diseases
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 10, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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