Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
Healthy Volunteers
ID06152081

A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel LumiCare™ Rinse and QLF Imaging Device

Led by Tufts University · Updated on 2025-08-05

60

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two caries detection methods to compare their effectiveness in identifying the progression of dental caries. This study focuses on a novel LumiCare™ rinse and the existing QLF Inspektor Pro Imaging device. Additionally, it aims to compare how carious lesions progress between patients who use e-cigarettes or vapes and those who do not. All participants will undergo assessments using both caries detecting devices at each research visit. For the LumiCare™ rinse, teeth will be cleaned, dried, and rinsed with the product, followed by blue light examination for fluorescent signals. The QLF device will also be used to capture images of the teeth after cleaning and drying, which will be analyzed for green fluorescence indicating caries. Participants will attend visits where their teeth are examined using both devices. Researchers will evaluate changes in fluorescence over 12 months to measure caries progression. The study will track caries development related to vaping habits and compare results between users and non-users. Safety monitoring and routine dental care will continue throughout the study period, which spans at least 12 months.

CONDITIONS

Brief Title

Caries Detection With Two Different Caries Detecting Devices

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of TUSDM Comprehensive Care Clinic
  • Adults aged 21 years or older
  • Classified as extreme or high caries risk by TUSDM CAMBRA form
  • Presence of 2 or more initial active primary carious lesions on free coronal tooth surfaces
  • At least 1 cavitated caries lesion present
  • Updated bite wing radiographs no older than 6 months
  • Patients who report yes or no to using e-cigarettes or vapes
  • Presence of 1 active caries, 1 inactive caries, and 1 sound tooth surface
Not Eligible

You will not qualify if you...

  • Classified as low or moderate caries risk by TUSDM CAMBRA form
  • No clinically detectable carious lesions on free coronal surfaces
  • No cavitated caries lesions
  • Carious teeth with lesions alongside extrinsic stains, fluorosis, or developmental defects
  • Patients who use conventional cigarettes or smokeless tobacco

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 12 months

Participants will have two caries detecting devices used during each research visit to assess dental caries.

Multiple visits over 12 months

Trial Site Locations

Total: 1 location

1

Tufts University School of Dental Medicine

Boston, Massachusetts, United States, 02111

Actively Recruiting

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Research Team

K

Karina Irusa, BDS,MS

A

Ann-Marie Billig

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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