跳至主要内容
临床试验/NCT03379337
NCT03379337已完成不适用

Pilot Study of a Modular Fluorescent Device With Interchangeable Heads to Identify Oral Diseases

Massachusetts Institute of Technology0 个研究点目标入组 28 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
In focus images of all 4 incisors and all 4 canines using devices

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-
  • Subjects with identifiable dental diseases must have otherwise healthy tissues/structures in which to control against.

排除标准

  • Subjects under 18 years of age will not be invited to participate

研究组 & 干预措施

Dental imaging

Experimental

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

干预措施: Dental imaging (Diagnostic Test)

结局指标

主要结局

In focus images of all 4 incisors and all 4 canines using devices

时间窗: 5 minutes for each imaging device used in the study.

Images of target teeth with imaging devices.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验