An observational study in Oral Inflammation, sponsored by Oral Science International Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Oral Science International Inc. · Observational
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 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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 400 is above the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →Oral Science International Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals visiting a dental clinic for a regular exam.
Exclusion Criteria:
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.
Bleeding on Probing (BOP)
Confirmation of oral inflammation if BOP is equal or above 10%
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Oral Science International Inc.