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PerioMonitor for Oral Inflammation

N/A
Recruiting
Led By Samuel B Low
Research Sponsored by Oral Science International Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with known severe oral diseases such as oral cancer
Subject with altered mental status or inability to provide informed consent or follow the procedure of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-month
Awards & highlights

Summary

This trial aims to test how easy it is to use PerioMonitor™ in a medical clinic and see if referring patients with high oral inflammation from physicians to dentists is effective. PerioMonitor™

Who is the study for?
This trial is for adults over 18 who may have oral inflammation. It's designed to test the PerioMonitor device in a medical clinic setting and see if it helps doctors refer patients with high oral inflammation to dentists.
What is being tested?
The study is testing the PerioMonitor, an In Vitro Diagnostic device used by healthcare professionals at point-of-care locations to detect signs of oral inflammation.
What are the potential side effects?
Since the PerioMonitor is a diagnostic tool rather than a medication or invasive procedure, there are no direct side effects associated with its use.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe oral diseases like oral cancer.
Select...
I am able to understand and follow the study's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comfort to participants
Ease of Test Performance
Ratio (%) of valid tests/performed tests
+1 more
Secondary study objectives
Proportion (%) of compliant participants with the recommended visit to a Dental Specialist
Proportion (%) of participants referred to a Dental Specialist
Proportion (%) participants referred to a Dental Specialist

Trial Design

1Treatment groups
Experimental Treatment
Group I: PerioMonitorExperimental Treatment1 Intervention

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Who is running the clinical trial?

Oral Science International Inc.Lead Sponsor
2 Previous Clinical Trials
517 Total Patients Enrolled
Samuel B LowPrincipal InvestigatorUniversity of Florida
~667 spots leftby Jan 2025