Oral Imaging for Porphyrin Biomarkers

Dental Plaque Clinical Trial

Official title:

Pilot Study of a Modular Fluorescent Device With Interchangeable Heads to Identify Oral Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379337
• Other study ID #: 1603518893
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: April 2019
• Source: Massachusetts Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to use the principle of fluorescence to identify oral diseases not readily visible to the naked eye. A imaging device with a removable and modular head consisting of arrays of Light Emitting Diodes (LEDs) with differing wavelengths (405nm,450nm or white) was used to image teeth to detect fluorescent biomarkers such as porphyrins associated with poor oral health (plaque). The process utilizes illumination of the teeth and gums using a specific array of LEDs in the visible and near-visible spectrum and is non-invasive. Successful implementation of the device would provide proof-of- concept validation for its use as a safe, rapidly deployable solution to assess oral hygiene.

Description:

To use the device, an interchangeable head with a specific LED wavelength was selected (to target a specific oral disease). The optical filter can be exchanged for another if necessary (this is done prior to the subject visit as to not prolong the time of the visit). During operation, LED intensity can be altered using the rotary dimmer switch. The procedure took place during a routine dental visit once consent was obtained. The device was covered in a clear disposable plastic sheath (Consolidated Plastics, Stow, OH) or equivalent sterile disposable camera bag. After both the subject and clinician wore UV protective eyeware, a series of images and videos were taken. These included detailed frames of all 4 incisors and all 4 canines. A video of the camera aperture passing over the select teeth was also taken. Additional images focusing on areas of interest to the clinician were taken, with area of capture and device mode recorded. The total time required to capture all images and video is expected to be approximately 5 minutes. As a control, an Acteon Soprocare a commercial device operating under the same fluorescence principle was also used. Images and video of the aforementioned eight target teeth in each mode were similarly captured for comparison to the test device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-70. Subjects with identifiable dental diseases must have otherwise healthy tissues/structures in which to control against.

Exclusion Criteria:

Subjects under 18 years of age will not be invited to participate

Related Conditions & MeSH terms

• Dental Plaque

Intervention

Diagnostic Test:
• Dental imaging
The target teeth positions for imaging included 4 incisors and all 4 canines. Only the vestibular and interproximal regions were of interest. Images were taken of these target teeth positions regardless of whether or not they exhibited plaque, consisted of full or partial restorations, contained major cracks/fractures, chips, or were missing. Other captured images included any abnormality of the tooth or gum exhibiting red fluorescence physically accessible by the devices.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Institute of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In focus images of all 4 incisors and all 4 canines using devices	Images of target teeth with imaging devices.	5 minutes for each imaging device used in the study.