Optical Imaging for Gum Disease

Overseen By Jing Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Eye diseases, Eye surgeries, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new optical imaging method for examining the mechanical properties of tissues, which can aid in understanding conditions like gum disease and keratoconus (a condition where the cornea thins and bulges). Researchers will use optical imaging on both healthy tissues, such as the cornea, skin, and gums, and on corneas affected by mild or moderate keratoconus. Individuals with mild or moderate keratoconus or healthy individuals without eye or skin issues might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better diagnostic tools.

Will I have to stop taking my current medications?

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

What prior data suggests that optical imaging of tissues is safe?

Research has shown that optical imaging, particularly Optical Coherence Tomography (OCT), is generally safe for people. OCT is non-invasive, meaning it doesn't require cuts or harmful substances. Studies have demonstrated that it can produce clear images of tissues without causing harm.

In previous studies, OCT was used on various tissues, such as the gums and eyes, without any reports of serious side effects. These results suggest that the technique is well-tolerated. Whether used on healthy skin, gums, or eyes with keratoconus (a condition affecting the cornea), OCT has consistently been safe in research settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about optical imaging for gum disease because it offers a non-invasive way to examine tissues, which is different from traditional methods like probing or X-rays. This technique provides real-time, high-resolution images, allowing for early detection of gum issues without discomfort. By targeting the condition with precision, optical imaging has the potential to improve diagnosis and monitoring, making dental care more proactive and personalized.

What evidence suggests that optical imaging is effective for gum disease?

Research has shown that Optical Coherence Tomography (OCT) effectively captures detailed images of gum tissues. This non-invasive method, which requires no surgery or cutting, provides clear, real-time images that aid in diagnosing gum disease. Studies have found that OCT accurately assesses both soft and hard tissues, making it useful for identifying issues in the gums and other areas. Additionally, OCT is a preferred choice for diagnosing various oral conditions due to its detailed imaging. In this trial, participants will undergo optical imaging of the gingiva to explore its potential in assessing gum health and detecting gum disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Seok-Hyun Yun, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people aged 18-75 with healthy eyes. It's designed to test a new imaging technique on various tissues, including gums, skin, and corneas.

Inclusion Criteria

I am between 18 and 75 years old with healthy skin.

I am 18-40 years old with mild or moderate keratoconus.

Exclusion Criteria

Group 1: Subjects allergic to anesthetic eyedrop, especially proparacaine

I have had eye diseases or surgeries in the past.

Group 1: Subjects with severe allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Optical imaging of the cornea, skin, and gingiva in healthy subjects and cornea in keratoconus subjects

1 year

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optical imaging of the tissues

Trial Overview

The study is testing OCT Vibrography (OCT elastography), an optical imaging method that measures how stiff or elastic human tissues are without needing surgery.

How Is the Trial Designed?

Group I: Keratoconus cornea Experimental Treatment 1 Intervention

Optical imaging of the cornea in mild and moderate keratoconus

Group II: Healthy skin Experimental Treatment 1 Intervention

Optical imaging of the skin in healthy subjects

Group III: Healthy gingiva Experimental Treatment 1 Intervention

Optical imaging of the gingiva in healthy subjects

Group IV: Healthy cornea Experimental Treatment 1 Intervention

Optical imaging of the cornea in healthy subjects

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Massachusetts Eye and Ear Infirmary

Collaborator

Trials

115

Recruited

15,000+

Published Research Related to This Trial

Optical coherence tomography (OCT) is a noninvasive imaging technique that provides detailed internal images of biological tissues with a resolution of 1 to 15 μm, making it useful across various medical fields without the need for biopsies or X-rays.

OCT is particularly valuable in ophthalmology for diagnosing retinal conditions, but its applications are expanding into cardiology, gastroenterology, pulmonology, oncology, dermatology, and even conservation of art, highlighting its versatility and safety in medical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Optical Coherence Tomography in Dental Diagnostics: A State-of-the-Art Review. Machoy, M., Seeliger, J., Szyszka-Sommerfeld, L., et al.[2023]

Dental optical coherence tomography (OCT) is a promising imaging technique that can effectively visualize oral tissues and diagnose conditions like caries, periodontal disease, and oral cancer.

The review highlights the advantages of OCT over traditional diagnostic methods, including its ability to provide high-resolution images and real-time assessment of oral health, although it also notes some limitations in the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental optical coherence tomography. Hsieh, YS., Ho, YC., Lee, SY., et al.[2021]

Optical coherence tomography (OCT) effectively differentiates between various human oral tissues, such as enamel, cortical bone, trabecular bone, and fatty tissue, based on qualitative and quantitative analyses.

The study found that OCT provided comparable information to cone beam computed tomography regarding tissue properties, indicating its potential as a reliable imaging technique for assessing hard and soft tissues in oral applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue characterization using optical coherence tomography and cone beam computed tomography: a comparative pilot study. Mahdian, M., Salehi, HS., Lurie, AG., et al.[2017]

This study provides in vivo optical coherence tomography (OCT) cross sections of the human oral mucosa from 47 adult volunteers, addressing the lack of reliable imaging methods for oral diagnostics.

The collected OCT data will be used for a randomized blinded image analysis to assess the superficial layers of the oral mucosa and correlate them with traditional histology, potentially improving diagnostic accuracy in dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Endoscopic Optical Coherence Tomography of the Healthy Human Oral Mucosa: Qualitative and Quantitative Image Analysis. Albrecht, M., Schnabel, C., Mueller, J., et al.[2020]

Optical coherence tomography (OCT) has been successfully used to visualize periodontal structures and assess treatment outcomes in 14 patients with periodontal disease, demonstrating its potential as a noninvasive tool for dental practice.

The study showed that OCT can effectively identify improvements in periodontal health, such as reductions in gingival thickness and biofilm, over a follow-up period of up to 90 days, indicating its usefulness in monitoring treatment progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography follow-up of patients treated from periodontal disease. Fernandes, LO., Mota, CCBO., Oliveira, HO., et al.[2020]

Optical coherence tomography (OCT) can effectively visualize and measure the thickness of periodontal tissues, including gingiva and alveolar bone, in real-time, providing a non-invasive method for assessing periodontal health in 30 volunteers.

The study established that OCT can measure internal structures like the biologic width, with average measurements of gingival thickness at 1.06 mm and biologic width at 2.09 mm, although imaging clarity can vary and is limited to a depth of about 1.5 mm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observation and determination of periodontal tissue profile using optical coherence tomography. Kakizaki, S., Aoki, A., Tsubokawa, M., et al.[2018]

In a study involving 50 patients with oral lesions, non-invasive optical coherence tomography (OCT) showed excellent agreement with standard biopsy and histopathology for diagnosing oral dysplasia and malignancy, indicating its reliability as a diagnostic tool.

The sensitivity and specificity of OCT for detecting oral premalignancy and malignancy were found to be very good, highlighting its potential as an effective non-invasive imaging method in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo diagnosis of oral dysplasia and malignancy using optical coherence tomography: preliminary studies in 50 patients. Wilder-Smith, P., Lee, K., Guo, S., et al.[2021]

A new optical coherence tomography (OCT) system has been developed that can produce high-resolution images of both hard and soft tissues in the oral cavity, specifically demonstrating its capability in imaging porcine periodontal tissues.

This is the first time OCT has been applied to biologic hard tissue imaging, suggesting it could be a valuable tool for diagnosing periodontal diseases by clearly visualizing critical interfaces like enamel-cementum and gingiva-tooth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of hard- and soft-tissue structure in the oral cavity by optical coherence tomography. Colston, BW., Everett, MJ., Da Silva, LB., et al.[2022]

Optical coherence tomography (OCT) is a safe, noninvasive imaging technique that provides detailed cross-sectional images of oral tissues, allowing for the evaluation of both hard and soft tissue health without using ionizing radiation.

OCT can detect early stages of dental and periodontal diseases, including demineralization, caries, and precancerous lesions, enabling real-time monitoring and diagnosis that traditional methods cannot achieve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography diagnostic imaging. Gimbel, C.[2008]

Optical coherence tomography (OCT) successfully differentiated between normal and pathological oral tissues in a study of 73 patients with 78 suspicious lesions, achieving high identification rates for key tissue structures: 93.5% for the epithelial layer and 94% for the basement membrane.

While OCT showed promise in identifying various tissue pathologies, it was not able to provide sufficient cellular detail to grade oral premalignant disorders, indicating a need for further research to enhance its diagnostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structural validation of oral mucosal tissue using optical coherence tomography. Hamdoon, Z., Jerjes, W., Al-Delayme, R., et al.[2021]

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Use of Optical Coherence Tomography in Dentistry - Janjua

OCT will be considered a gold standard diagnostic tool for the detection and characterization of several conditions and lesions of the orofacial region.

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mdpi.com

mdpi.com/2076-3417/11/22/11025

Potential Imaging Capability of Optical Coherence ...

In this study, periodontal conditions of 14 human subjects with periodontal disease were evaluated using OCT on days 0, 30, 60, and 90 following treatment. The ...

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withpower.com

withpower.com/trial/phase-corneas-2-2023-bcd40

Optical Imaging for Gum Disease

Optical imaging techniques like Optical Coherence Tomography (OCT) are generally considered safe for humans as they are non-invasive and do not use harmful ...