Oral Imaging for Porphyrin Biomarkers
Pilot Study of a Modular Fluorescent Device With Interchangeable Heads to Identify Oral Diseases
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 15, 2017
CompletedFirst Posted
Study publicly available on registry
December 20, 2017
CompletedApril 3, 2019
April 1, 2019
3 months
December 15, 2017
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Dental imaging
EXPERIMENTAL4 incisors and 4 canine teeth of subjects were imaged with the experimental and the commercial device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults aged 18-70. Subjects with identifiable dental diseases must have otherwise healthy tissues/structures in which to control against.
You may not qualify if:
- Subjects under 18 years of age will not be invited to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29284461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pratik Shah, Ph.D.
Massachusetts Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2017
First Posted
December 20, 2017
Study Start
April 1, 2016
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
April 3, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share