PerioMonitor for Oral Inflammation

Overseen By Julie Struthers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oral Science International Inc.

Disqualifiers: Altered mental status, Oral cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well a new device, the PerioMonitor, detects oral inflammation (swelling and irritation in the mouth) in clinics and its effectiveness in referring patients to dentists when necessary. The trial aims to determine if doctors and dentists can use this tool to identify patients with high oral inflammation more efficiently. Suitable participants show noticeable signs of oral inflammation but do not have severe oral diseases like oral cancer. Participants must speak English and be able to consent to the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance oral health diagnostics.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PerioMonitor device is safe for detecting oral inflammation?

Research shows that PerioMonitor™ detects inflammation in the mouth by measuring oral neutrophils, which are white blood cells that respond to inflammation. Although specific safety data from past studies on PerioMonitor™ is unavailable, it is generally considered low-risk as an In Vitro Diagnostic (IVD) device. IVD devices are typically safe because they do not involve taking medicine or undergoing invasive procedures. Instead, they provide information based on tests conducted outside the body, such as in a lab or at the point of care. For concerns about using PerioMonitor™, consulting a healthcare provider is advisable. They can offer personalized information based on individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PerioMonitor because it offers a new way to track and possibly manage oral inflammation using innovative monitoring technology. Unlike traditional treatments that focus on reducing inflammation through medications or dental procedures, PerioMonitor aims to provide real-time data on a patient's oral health status. This could lead to more personalized and timely interventions, potentially improving outcomes for people with periodontal issues. As a non-invasive method, it promises a more comfortable experience for patients while enhancing the precision of treatment plans.

What evidence suggests that the PerioMonitor device is effective for detecting oral inflammation?

Research has shown that PerioMonitor, the investigational tool studied in this trial, effectively detects oral inflammation. It checks for signs of inflammation quickly and easily, without causing discomfort. This test is simple to use in clinics and dental offices. Studies have found it to be a promising tool for early detection of inflammation, which can enhance oral health management. ^{1 6 7 8 9}

Who Is on the Research Team?

Samuel B Low

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject fluent in English

Subject has signed the Informed Consent Form (ICF)

Exclusion Criteria

Previous enrollment into the current study

I do not have severe oral diseases like oral cancer.

I am able to understand and follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation

Participants undergo PerioMonitor testing to detect oral inflammation

1 day

1 visit (in-person)

Referral and Follow-up

Participants identified with high oral inflammation are referred to a dental specialist, and their compliance with the referral is monitored

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PerioMonitor

Trial Overview 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.

How Is the Trial Designed?

Group I: PerioMonitor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Oral Science International Inc.

Lead Sponsor

Trials

3

Recruited

620+

Published Research Related to This Trial

In a study of 113 patients with mild pericoronitis, significant correlations were found between pain levels and quality-of-life outcomes, indicating that pain affects daily routines, social life, and oral functions.

Most participants reported low pain levels, but even these were clinically important, suggesting that pericoronitis pain can negatively impact lifestyle and oral function, which is often overlooked in clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain with pericoronitis affects quality of life. Magraw, CB., Golden, B., Phillips, C., et al.[2022]

In patients with plaque-induced gingivitis, there are significant changes in sensory thresholds, with decreased sensitivity to cold and heat detection, but increased sensitivity to pressure pain at the gingiva compared to healthy controls.

These findings suggest that gingivitis affects somatosensory function in a complex way, leading to both hypoesthesia (reduced sensitivity) and hyperesthesia (increased sensitivity), which could impact oral health and patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatosensory profiling of patients with plaque-induced gingivitis: a case-control study. Wang, C., Zhou, X., Chen, Y., et al.[2020]

In a study on rats, neurogenic inflammation in the oral mucosa was shown to involve the release of mediators like substance P and calcitonin gene-related peptide, leading to symptoms such as vasodilation and increased plasma leakage.

Capsaicin pretreatment, which reduces the presence of substance P fibers, effectively prevents the inflammatory responses, suggesting that different mechanisms are responsible for increased vascular permeability and decreased vascular resistance during inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurogenic inflammation and the oral mucosa. Györfi, A., Fazekas, A., Rosivall, L.[2019]

Orofacial pain conditions, such as toothache and TMJ disorders, are linked to inflammation in orofacial tissues and involve complex neural mechanisms, including both peripheral and central sensitization.

Recent research highlights the significant role of non-neural processes, particularly glial cells, in contributing to the pain experienced in these inflammatory states.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral and central mechanisms of orofacial inflammatory pain. Sessle, BJ.[2022]

A review of 32 studies indicates that specific inflammatory mediators, such as interleukin-8 and tumor necrosis factor-α, are expressed at higher levels during pulp inflammation, which can help distinguish between reversible and irreversible pulpitis.

Quantifying these inflammatory mediators in situ could improve clinical diagnosis and treatment outcomes for vital pulp therapy, potentially leading to better preservation of pulp vitality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulp Inflammation Diagnosis from Clinical to Inflammatory Mediators: A Systematic Review. Zanini, M., Meyer, E., Simon, S.[2022]

In a study of 100 community-based children aged 7 to 12, those with mixed joint and muscle pain (GJMM) showed significantly higher pain intensity and lower pressure pain thresholds (PPT) in the temporalis and masseter muscles compared to other groups.

The findings suggest that manual palpation (MP) is effective in identifying symptomatic children with temporomandibular disorders (TMD), and the observed changes in pain perception may indicate a mechanism of central sensitization in those experiencing mixed pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in pain perception in children reporting joint and orofacial muscle pain. Chaves, TC., Nagamine, HM., de Sousa, LM., et al.[2022]

The review highlights the importance of patient-reported outcome (PRO) metrics in periodontics, emphasizing that both the questions asked and the timing of these questions are crucial for effective study design.

The authors provide guidelines based on randomized controlled trials that track pain after dental interventions, which can help identify peak pain times and improve the assessment of patient experiences during soft tissue augmentation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: incorporating patient-reported outcomes in periodontal clinical trials. McGuire, MK., Scheyer, ET., Gwaltney, C.[2014]

Recent research has advanced our understanding of pain mechanisms, particularly regarding local tissue mediators like neuropeptides that contribute to inflammation.

The introduction of clinical microdialysis and superfusion of dental pulp as new methods allows for better measurement of inflammatory mediators, enhancing our ability to study and manage orofacial pain effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology of peripheral neuropeptide and inflammatory mediator release. Hargreaves, KM., Swift, JQ., Roszkowski, MT., et al.[2019]

A new method using infrared photography and image-processing technology can objectively evaluate oral ulcerative lesions by measuring inflammation and healing parameters, which is currently lacking in clinical practice.

In a study involving 8 subjects, this technique successfully quantified the area of ulceration and changes in inflammatory intensity over time, demonstrating its potential for monitoring healing progression in oral lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided analysis of intraoral ulcerative lesions. Wilson, J., Firnhaber, R., Kutcher, MJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05153798

Evaluation of PerioMonitor for Detection of Oral Inflammatory ... The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the presumptive detection of ...

2. periomonitor.com periomonitor.com/articles/periomonitor-white-paper.pdf

A Game-Changer in Chairside Oral Inflammation Detection PerioMonitor™ is a rapid, non-invasive, point-of-care test designed to detect oral inflammation through the measurement of neutrophil enzyme activity (NEA) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06570044

Evaluation of PerioMonitor for Detection of Oral ... 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 ...

4. withpower.com withpower.com/trial/phase-oral-inflammation-6-2024-60332

PerioMonitor for Oral Inflammation · Info for Participants The research on patient-reported outcomes in periodontal clinical trials suggests that tracking pain and other symptoms over time can help assess the ...

5. pro.oralscience.com pro.oralscience.com/blogs/news/periomonitor-developed-by-oral-science-receives-class-iii-medical-device-license-from-health-canada-shipments-planned-for-june-2025-nbsp?srsltid=AfmBOoqz7pKXKl1g1H0zQ2u2IgGTrtlJu6rBxsrvRriznWHpb49SIVN_

PerioMonitor™, Developed by Oral Science, Receives ... This first-of-its-kind test offers a rapid, cost-effective, and user-friendly method for assessing inflammation in dental practices.

6. periomonitor.com periomonitor.com/

PerioMonitor™ PerioMonitor measures oral neutrophils—white blood cells released in response to local inflammation in the mouth. It provides an objective snapshot of oral ...

7. trial.medpath.com trial.medpath.com/clinical-trial/962150bbccaf6ca5/nct05153798-evaluation-periomonitor-oral-inflammatory-load

Evaluation of PerioMonitor for Detection of Oral Inflammatory ... The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the presumptive detection ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507281/

FDA approval of an AI model for diagnosis of periodontal ... The recent Food and Drug Administration approval of Videa Perio Assist (VPA), an AI model for diagnosing periodontal diseases, presents a breakthrough in ...

9. go.drugbank.com go.drugbank.com/conditions/DBCOND0028177

Periodontal Disease (DBCOND0028177) Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects, No drug interventions, Not Available, Not Available, unknown_status.