Caries,Dental
Conditions
Brief 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.
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.
Sponsors
Tufts University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of two caries-detecting devices | 12 months | Compare the effectiveness of the two caries detecting devices in their ability determining caries progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries progression in those who do and do not use e-cigarettes/vapes | 12 months | Comparison of the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not |
Countries
United States
Contacts
Primary ContactKarina Irusa, BDS,MS
Backup ContactAnn-Marie Billig
Outcome results
None listed