Trials / Unknown
UnknownNCT05886855
Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 400 (estimated)
- Sponsor
- Oral Science International Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
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.
Conditions
Timeline
- Start date
- 2023-05-24
- Primary completion
- 2023-12-20
- Completion
- 2024-01-31
- First posted
- 2023-06-02
- Last updated
- 2023-06-02
Source: ClinicalTrials.gov record NCT05886855. Inclusion in this directory is not an endorsement.