Caries,DentalNCT06152081
Caries Detection With Two Different Caries Detecting Devices
A study testing LumiCare rinse and QLF Inspektor Pro Imaging in people with Caries,Dental, run by Tufts University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- LumiCare rinse and QLF Inspektor Pro Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools
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
- Being tested
- LumiCare rinse, QLF Inspektor Pro Imaging
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants enrolled in the study will have the two caries detecting devices used during each research visit. Receives: Device: LumiCare rinse; Device: QLF Inspektor Pro Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of two caries-detecting devices
Compare the effectiveness of the two caries detecting devices in their ability determining caries progression
Measured: 12 months
Secondary outcomes (1)
Caries progression in those who do and do not use e-cigarettes/vapes
Comparison of the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karina Irusa, BDS, MS, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152081
- Sponsor's protocol ID
- STUDY00003913
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools
- ClinicalTrials.gov ID
- NCT06152081
- Acronym / sponsor ID
- STUDY00003913
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Device: LumiCare rinse, Device: QLF Inspektor Pro ImagingAll participants enrolled in the study will have the two caries detecting devices used during each research visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumiCare rinseThe 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 | All Participants |
| QLF Inspektor Pro ImagingThe 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. | Device | All Participants |
Primary outcome
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
1 secondary outcome
Caries progression in those who do and do not use e-cigarettes/vapes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karina Irusa, BDS, MS principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LumiCare rinse and QLF Inspektor Pro Imaging in people with Caries,Dental, run by Tufts University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karina Irusa, BDS,MS (6176362408, dentalresearchadministration@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two caries-detecting devices (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.