Oral Imaging for Porphyrin Biomarkers
Primary Purpose
Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dental imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Dental Plaque focused on measuring Imaging
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dental imaging
Arm Description
4 incisors and 4 canine teeth of subjects were imaged with the experimental and the commercial device.
Outcomes
Primary Outcome Measures
In focus images of all 4 incisors and all 4 canines using devices
Images of target teeth with imaging devices.
Secondary Outcome Measures
Full Information
NCT ID
NCT03379337
First Posted
December 15, 2017
Last Updated
April 1, 2019
Sponsor
Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03379337
Brief Title
Oral Imaging for Porphyrin Biomarkers
Official Title
Pilot Study of a Modular Fluorescent Device With Interchangeable Heads to Identify Oral Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental imaging
Arm Type
Experimental
Arm Description
4 incisors and 4 canine teeth of subjects were imaged with the experimental and the commercial device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dental imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
In focus images of all 4 incisors and all 4 canines using devices
Description
Images of target teeth with imaging devices.
Time Frame
5 minutes for each imaging device used in the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratik Shah, Ph.D.
Organizational Affiliation
Massachusetts Institute of Technology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29284461
Citation
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.
Results Reference
derived
Learn more about this trial
Oral Imaging for Porphyrin Biomarkers
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