RecruitingNot ApplicableNCT06152081

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

Sponsor

Tufts University

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Caries,Dental

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria8

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
active caries, 1 inactive caries and 1 sound tooth surface.

Exclusion Criteria5

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

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Interventions

DEVICELumiCare 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.

DEVICEQLF 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.