Recruiting

Caries Detection

Sponsor:

Tufts University

Code:

NCT06152081

Conditions

Caries,Dental

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

LumiCare rinse

QLF Inspektor Pro Imaging

Study Details

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.

Conditions

Caries,Dental

Study ID

NCT06152081

Start date

Apr 1, 2025

Status verified date

Aug, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: All Participants

All participants enrolled in the study will have the two caries detecting devices used during each research visit.

Interventions

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.

Primary outcome measure

  • Comparison of two caries-detecting devices [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Karina Irusa, BDS,MS

6176362408dentalresearchadministration@tufts.edu

Ann-Marie Billig

6176363931dentalresearchadministration@tufts.edu

Locations

Tufts University School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02111

More Information

Sponsor

Tufts University

Last update posted

Aug 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tufts University on 2025-08-05.