Oral Imaging for Porphyrin Biomarkers

NCT ID: NCT03379337

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Dental Plaque

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dental imaging

4 incisors and 4 canine teeth of subjects were imaged with the experimental and the commercial device.

Group Type: EXPERIMENTAL

Dental imaging

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratik Shah, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Institute of Technology

References

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.

Reference Type: DERIVED

PMID: 29284461 (View on PubMed)

Other Identifiers

1603518893

Identifier Type: -

Identifier Source: org_study_id