Caries Detection Devices for Tooth Decay

Overseen By Ann-Marie Billig

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Low caries risk, No carious lesions, Conventional tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two tools, LumiCare rinse (a dental rinse) and QLF Inspektor Pro Imaging (an imaging device), to evaluate their effectiveness in detecting and tracking tooth decay. Researchers also aim to determine if e-cigarette or vape use affects tooth decay progression. Ideal participants are adults from the TUSDM clinic who have a high risk of cavities and at least one active cavity. As an unphased trial, this study allows participants to contribute to innovative dental research that could enhance future oral health diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these caries detection devices are safe?

Research has shown that the LumiCare rinse helps dentists see tooth decay more clearly by using tiny particles that light up and adhere to decayed areas. The FDA has approved this rinse, indicating it meets certain safety standards for its intended use. However, detailed safety information for LumiCare in humans remains limited.

The QLF Inspektor Pro Imaging employs a special light to detect tooth decay by identifying changes in the glow emitted by decaying teeth. Like LumiCare, specific safety details for humans are limited. However, dental offices frequently use QLF technology, suggesting it is generally considered safe.

While both LumiCare and QLF are used in dental care, the lack of specific safety data makes it important for participants to discuss any concerns with their healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the caries detection devices LumiCare rinse and QLF Inspektor Pro Imaging because they offer innovative ways to identify tooth decay early. Unlike traditional methods that rely on visual examination and X-rays, LumiCare uses a special rinse that highlights decayed areas, making them more visible. QLF Inspektor Pro Imaging takes it a step further with advanced imaging technology that can detect decay in its earliest stages, potentially catching issues long before they would be visible to the naked eye or on standard X-rays. These advancements could lead to earlier interventions and better outcomes for dental health.

What evidence suggests that these caries detection devices are effective for tooth decay?

Studies have shown that the LumiCare rinse effectively detects different stages of tooth decay, being over 60 times more likely to identify active decay compared to healthy teeth. Meanwhile, the QLF Inspektor Pro Imaging effectively spots various types of tooth decay and provides clear images that assist both patients and dentists. It also reliably tracks changes in teeth over time. In this trial, all participants will use both the LumiCare rinse and QLF Inspektor Pro Imaging during each research visit, as both treatments show strong promise in accurately identifying and monitoring tooth decay. ^{1 2 4 5 6}

Who Is on the Research Team?

Karina Irusa, BDS, MS

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 21 at high risk of tooth decay, with at least two active caries and one cavitated lesion. Participants must have recent bite-wing X-rays and a mix of active, inactive, and sound teeth. Both e-cigarette users and non-users can join if they're patients at TUSDM Comprehensive Care Clinic.

Inclusion Criteria

Patients of TUSDM Comprehensive Care Clinic

Patients who responded either yes/no to use of e-cigarettes/vapes

Presence of at least 1 cavitated lesion

Exclusion Criteria

No cavitated caries lesions

No clinically detectable carious lesions on free coronal surfaces

Patients who responded yes to the use of conventional cigarettes or smokeless tobacco

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will have the two caries detecting devices used during each research visit to compare the effectiveness of the novel LumiCare™ rinse and QLF in determining caries progression

12 months

Regular visits (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LumiCare rinse
• QLF Inspektor Pro Imaging

Trial Overview The study aims to compare the effectiveness of LumiCare™ rinse with QLF Inspektor Pro Imaging in tracking tooth decay progression. It also looks into how caries progress in e-cigarette/vape users versus non-users.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10027680/

Evaluation of a novel caries detecting oral rinse - PMC LC Rinse can distinguish between active caries, inactive caries and hypomineralization, and can augment caries detection with high sensitivity, specificity, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06152081

Study Details | NCT06152081 | Caries Detection With Two ... 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 ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200601.pdf

March 29, 2021 GreenMark Biomedical Inc. Prithul Bom ... LumiCare™ Caries Detection Rinse is indicated to aid the dental professional in visualization of carious lesions. The Indications for Use ...

4. withpower.com withpower.com/trial/phase-dental-caries-2024-e3d9e

Caries Detection Devices for Tooth Decay The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression.

5. scispace.com scispace.com/papers/evaluation-of-a-novel-caries-detecting-oral-rinse-1zjm1asw

Evaluation of a novel caries detecting oral rinse Results With selected teeth, active caries were 638.6 times (60.05 with full dentition) more likely to have positive LC Rinse response than sound surfaces and ...

6. greenmark.bio greenmark.bio/product/lumicare-caries-detection-rinse/

LumiCare™ Caries Detection Rinse The LumiCare™ Rinse is a water-based solution containing patented fluorescent sub-micron starch particles that have been functionalized to target and adhere to ...