Caries Detection With Two Different Caries Detecting Devices

A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools

The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression. The secondary aim is to compare the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not.

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Device: LumiCare rinse; Device: QLF Inspektor Pro Imaging

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karina Irusa, BDS,MS; Phone Number: 6176362408; Email: dentalresearchadministration@tufts.edu
• Study Contact Backup: Name: Ann-Marie Billig; Phone Number: 6176363931; Email: dentalresearchadministration@tufts.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients of TUSDM Comprehensive Care Clinic
• Adult patients over the age of 21
• Extreme/High Caries Risk classification per TUSDM Caries Management by Risk Assessment (CAMBRA) form
• Presence of 2 or more initial active primary carious lesions on a free coronal surface of any tooth by visual assessment, QLF, and LumiCare™
• Presence of at least 1 cavitated lesion
• Updated (no more than 6 months old) bite wing radiographs available.
• Patients who responded either yes/no to use of e-cigarettes/vapes
• 1 active caries, 1 inactive caries and 1 sound tooth surface.

Exclusion Criteria:

• Low or moderate caries risk classification per TUSDM CAMBRA form
• No clinically detectable carious lesions on free coronal surfaces
• No cavitated caries lesions
• Carious teeth with caries lesions concomitant with extrinsic stains, fluorosis, or developmental defects.
• Patients who responded yes to the use of conventional cigarettes or smokeless tobacco

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All Participants; All participants enrolled in the study will have the two caries detecting devices used during each research visit.

Device: LumiCare rinse; The teeth being assessed will be cleaned of any debris ,plaque and calculus. The areas being assessed will be air dried. A dry field will be maintained using cotton rolls and a saliva ejector. Lumicare rinse will be applied onto the test areas for 30 seconds and the excess removed using a saliva ejector. The sites will then be rinsed with plain water for 10 seconds and excess will be removed using high volume suction. A blue curing light will then be held 1-2 inches from the test surfaces while the examiner assesses the surfaces for the presence or absence of fluorescent illumination.; Device: QLF Inspektor Pro Imaging; The teeth being assessed will be cleaned of any debris ,plaque and calculus. The areas being assessed will be air dried. A dry field will be maintained using cotton rolls and a saliva ejector. The QLF device will be positioned over the tooth surface to be tested and an image will be taken. The images will be stored automatically and assessed by the examiners for the presence of green fluorescence using the QA2 program (Version 1.25, Inspektor Research systems BV, Amsterdam, The Netherlands) . The trend in green fluorescence will also be calculated using this software algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of two caries-detecting devices	Compare the effectiveness of the two caries detecting devices in their ability determining caries progression	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries progression in those who do and do not use e-cigarettes/vapes	Comparison of the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not	12 months

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Karina Irusa, BDS, MS, Tufts University School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: STUDY00003913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes