Caries Detection With Two Different Caries Detecting Devices

ConditionCaries,Dental

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorTufts University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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™

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

LumiCare rinse
Device
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.
QLF Inspektor Pro Imaging
Device
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.

Treatment groups

60 Participants

are divided into 1 treatment group

Group A: All ParticipantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Comparison of two caries-detecting devices

Compare the effectiveness of the two caries detecting devices in their ability determining caries progression

Time frame

12 months

Secondary outcomes

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Source ClinicalTrials.gov

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