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Oral Imaging for Porphyrin Biomarkers

Primary Purpose

Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dental imaging
Sponsored by
Massachusetts Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dental Plaque focused on measuring Imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 15, 2017
    Last Updated
    April 1, 2019
    Sponsor
    Massachusetts Institute of Technology
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    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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