Oral Imaging for Porphyrin Biomarkers

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Diagnostic test: Dental imaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Dental imaging; 4 incisors and 4 canine teeth of subjects were imaged with the experimental and the commercial device.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Massachusetts Institute of Technology
• Investigators: Principal Investigator: Pratik Shah, Ph.D., Massachusetts Institute of Technology

Publications and helpful links

General Publications

• Angelino K, Shah P, Edlund DA, Mohit M, Yauney G. Clinical validation and assessment of a modular fluorescent imaging system and algorithm for rapid detection and quantification of dental plaque. BMC Oral Health. 2017 Dec 28;17(1):162. doi: 10.1186/s12903-017-0472-4.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Imaging
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: 1603518893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No