Caries Detection With Two Different Caries Detecting Devices

Not Applicable

Not yet recruiting

• Conditions: Caries,Dental
• Interventions: Device: LumiCare rinse; Device: QLF Inspektor Pro Imaging

• Registration Number: NCT06152081
• Lead Sponsor: Tufts University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20
• Study Start: 2024-12
• Primary Completion: 2026-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	LumiCare rinse	All participants enrolled in the study will have the two caries detecting devices used during each research visit.
All Participants	QLF Inspektor Pro Imaging	All participants enrolled in the study will have the two caries detecting devices used during each research visit.

Primary Outcome Measures

Name	Time	Method
Comparison of two caries-detecting devices	12 months	Compare the effectiveness of the two caries detecting devices in their ability determining caries progression

Secondary Outcome Measures

Name	Time	Method
Caries progression in those who do and do not use e-cigarettes/vapes	12 months	Comparison of the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States