Oral Inflammation
Conditions
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).
Interventions
DIAGNOSTIC_TESTPerioMonitor
Collection of oral rinse specimen and perform the PerioMonitor test as per the method described in the instructions for use
Sponsors
Oral Science International Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* subject fluent in English * subject has signed the ICF
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 compliant participants with the recommended visit to a Dental Specialist | 6-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. |
| 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. |
Countries
United States
Outcome results
None listed