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Oral Imaging for Porphyrin Biomarkers

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ClinicalTrials.gov Identifier: NCT03379337
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Massachusetts Institute of Technology

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.

Condition or disease Intervention/treatment Phase
Dental Plaque Diagnostic Test: Dental imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of a Modular Fluorescent Device With Interchangeable Heads to Identify Oral Diseases
Study Start Date : April 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. In focus images of all 4 incisors and all 4 canines using devices [ Time Frame: 5 minutes for each imaging device used in the study. ]
    Images of target teeth with imaging devices.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379337


Sponsors and Collaborators
Massachusetts Institute of Technology
Investigators
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Principal Investigator: Pratik Shah, Ph.D. Massachusetts Institute of Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Massachusetts Institute of Technology
ClinicalTrials.gov Identifier: NCT03379337     History of Changes
Other Study ID Numbers: 1603518893
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massachusetts Institute of Technology:
Imaging

Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases