Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
- Conditions
- Oral Inflammation
- Registration Number
- NCT06570044
- Lead Sponsor
- Oral Science International Inc.
- Brief Summary
The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation.
PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- subject fluent in English
- subject has signed the ICF
- subject with altered mental status/inability to provide informed consent or follow the procedure of the Study
- Previous enrolment into the current Study
- Patients with known severe oral diseases such as oral cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Comfort to participants Day 0 Comfort to participants with sample collection (Yes/No). The Overall ratio (%) of discomfort ('No') as well as the ratio per operator will be measured.
Use error Day 0 Any issue encountered with collection of specimens and/or test reading. The overall ratio (%) of tests with use errors as well as the ratio per operator will be measured
Ratio (%) of valid tests/performed tests Day 0 The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed
Ease of Test Performance Day 0 The Ease-of-Test Performance will be evaluated by a 5-question questionnaire
- Secondary Outcome Measures
Name Time Method Proportion (%) participants referred to a Dental Specialist 12-Month The recommended course of action further to completion of the PerioMonitor test will be documented with a 4-item report form. The ratio (%) of participants referred to a dental specialist visit as the recommended course of action will be calculated.
Proportion (%) of participants referred to a Dental Specialist 6-Month The recommended course of action further to completion of the PerioMonitor test will be documented with a 4-item report form. The ratio (%) of participants referred to a dental specialist visit as the recommended course of action will be calculated.
Proportion (%) of compliant participants with the recommended visit to a Dental Specialist 12-Month Visits to a Dental Specialist will be monitored by querying participants' electronic medical records or by direct contact (email or phone) and data (visit date, treatment) will be documented in a report form.
The ratio (%) of participants who completed a visit to a Dental Specialist over all participants referred to a dental specialist visit as the recommended course of action will be calculated.
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Trial Locations
- Locations (1)
1st Family Medicine
🇺🇸Buckeye, Arizona, United States
1st Family Medicine🇺🇸Buckeye, Arizona, United States