Caries Detection With Three Different Caries Detecting Devices

Sponsor

Tufts University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152081

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and the CALCIVIS® Imaging System 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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental	Device: LumiCare rinse Device: Calcivis Dental Imaging Device: QLF Inspektor Pro Imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants All participants enrolled in the study will have the three caires detecting devices used during each research visit.	Device: 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. Device: Calcivis Dental 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 imaging device will be positioned over the tooth surfaces and activated. The imaging device will simultaneously apply the CALCIVIS photoprotein and take an image of the resulting bioluminescence. The imaging device will produce 2 images; one taken immediately before the photoprotein is applied and one after. Images will be assessed for the presence/absence of blue luminescence. Device: 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.

Arm

Intervention/Treatment

Experimental: All Participants

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

Device: 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.

Device: Calcivis Dental 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 imaging device will be positioned over the tooth surfaces and activated. The imaging device will simultaneously apply the CALCIVIS photoprotein and take an image of the resulting bioluminescence. The imaging device will produce 2 images; one taken immediately before the photoprotein is applied and one after. Images will be assessed for the presence/absence of blue luminescence.

Device: 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.

Outcome Measures

Primary Outcome Measures

Comparison of three caries-detecting devices [12 months]
Compare the effectiveness of the three caries detecting devices in their ability determining caries progression

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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, CALCIVIS® 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tufts University

Investigators

Principal Investigator: Karina Irusa, BDS, MS, Tufts University School of Dental Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karina Irusa, Assistant Professor, Comprehensive Care, Tufts University

ClinicalTrials.gov Identifier:

NCT06152081

Other Study ID Numbers:

STUDY00003913

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Nov 30, 2023