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

Tufts University1 site in 1 country60 target enrollmentApril 1, 2025

ConditionsCaries,Dental

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Caries,Dental
Sponsor: Tufts University
Enrollment: 60
Locations: 1
Primary Endpoint: Comparison of two caries-detecting devices
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2025

End Date

October 1, 2027

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tufts University

Responsible Party

Sponsor

Eligibility Criteria

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