Caries Detection With Two Different Caries Detecting Devices

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152081
• Other study ID #: STUDY00003913
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2027

Study information

• Verified date: March 2024
• Source: Tufts University
• Contact: Karina Irusa, BDS,MS
• Phone: 6176362408
• Email: dentalresearchadministration[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of two caries-detecting devices	Compare the effectiveness of the two caries detecting devices in their ability determining caries progression	12 months
Secondary	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