Caries Detection With Three Different Caries Detecting Devices

Study Overview
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Brief Summary
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The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and the CALCIVIS® Imaging System 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.

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

Conditions
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Caries,Dental

Intervention / Treatment
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* Device: LumiCare rinse
* Device: Calcivis Dental Imaging
* Device: QLF Inspektor Pro Imaging


Participation Criteria
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Eligibility Criteria
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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, CALCIVIS® 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>All participants enrolled in the study will have the three caires detecting devices used during each research visit. | Device: LumiCare rinse<br>* 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.<br>Device: Calcivis Dental Imaging<br>* 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 imaging device will be positioned over the tooth surfaces and activated. The imaging device will simultaneously apply the CALCIVIS photoprotein and take an image of the resulting bioluminescence. The imaging device will produce 2 images; one taken immediately before the photoprotein is applied and one after. Images will be assessed for the presence/absence of blue luminescence.<br>Device: QLF Inspektor Pro Imaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of three caries-detecting devices | Compare the effectiveness of the three 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 |