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

86 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PerioMonitor for oral inflammation?

The research on patient-reported outcomes in periodontal clinical trials suggests that tracking pain and other symptoms over time can help assess the effectiveness of treatments like PerioMonitor for managing oral inflammation. ^{1 2 3 4 5}

How does the PerioMonitor treatment for oral inflammation differ from other treatments?

The PerioMonitor treatment is unique because it likely focuses on monitoring and managing neurogenic inflammation, which involves nerve-related inflammatory processes in the oral mucosa. This approach may differ from standard treatments by targeting the release of specific inflammatory mediators like substance P and calcitonin gene-related peptide, which are involved in the nerve-related inflammation of oral tissues. ^{3 6 7 8 9}

What is the purpose of this trial?

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).

Research Team

Samuel B Low

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: PerioMonitor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Oral Science International Inc.

Lead Sponsor

Trials

3

Recruited

620+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pain with pericoronitis affects quality of life. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pulp Inflammation Diagnosis from Clinical to Inflammatory Mediators: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacology of peripheral neuropeptide and inflammatory mediator release. [2019]

4. Singapore pubmed.ncbi.nlm.nih.gov

Differences in pain perception in children reporting joint and orofacial muscle pain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Commentary: incorporating patient-reported outcomes in periodontal clinical trials. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Neurogenic inflammation and the oral mucosa. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Somatosensory profiling of patients with plaque-induced gingivitis: a case-control study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Computer-aided analysis of intraoral ulcerative lesions. [2019]