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NCT Number: NCT06152081

Caries Detection With Two Different Caries Detecting Devices

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.

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LumiCare rinse

Device

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

Device

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 outcomes

  1. Comparison of two caries-detecting devices

    Time frame: 12 months

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

Secondary outcomes

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

    Time frame: 12 months

    Comparison of the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not

Study contacts

Contact information is provided by the study sponsor or research team.

Ann-Marie Billig

CONTACT

[email protected]

6176363931

Karina Irusa, BDS,MS

CONTACT

[email protected]

6176362408

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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