NCT06152081

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Apr 2025Oct 2027

First Submitted

Initial submission to the registry

June 13, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

August 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

June 13, 2023

Last Update Submit

August 4, 2025

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (1)

  • Comparison of two caries-detecting devices

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

    12 months

Secondary Outcomes (1)

  • Caries progression in those who do and do not use e-cigarettes/vapes

    12 months

Study Arms (1)

All Participants

EXPERIMENTAL

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

Device: LumiCare rinseDevice: QLF Inspektor Pro Imaging

Interventions

LumiCare rinseDEVICE

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.

All Participants
QLF Inspektor Pro ImagingDEVICE

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.

All Participants

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • active caries, 1 inactive caries and 1 sound tooth surface.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Karina Irusa, BDS, MS

    Tufts University School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Irusa, BDS,MS

CONTACT

6176362408dentalresearchadministration@tufts.edu

Ann-Marie Billig

CONTACT

6176363931dentalresearchadministration@tufts.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

November 30, 2023

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

August 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)