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

Trial Summary

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 data supports the effectiveness of the treatment LumiCare rinse, QLF Inspektor Pro Imaging for detecting tooth decay?

Research shows that light-based diagnostic methods, like QLF (Quantitative Light-induced Fluorescence), can help detect early signs of tooth decay, which may allow for earlier treatment and prevention of further damage. ^{1 2 3 4 5}

Is the LumiCare rinse or QLF Inspektor Pro Imaging safe for humans?

The available research does not provide specific safety data for humans regarding LumiCare rinse or QLF Inspektor Pro Imaging, but these technologies have been used in clinical trials to detect tooth decay. ^{6 7 8 9 10}

How does the LumiCare rinse treatment for tooth decay differ from other treatments?

LumiCare rinse is unique because it is a starch-based oral rinse that helps detect active tooth decay by illuminating it under a dental curing light, enhancing the dentist's visual examination. This approach is different from other methods that rely on visual, tactile, or fluorescence-based detection alone. ^{6 7 10 11 12}

What is the purpose of this trial?

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.

Research Team

Karina Irusa, BDS, MS

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Light-based diagnostic methods for the in vivo assessment of initial caries lesions: Laser fluorescence, QLF and OCT. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Digital enhancement of radiographs for assessment of interproximal dental caries. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical visual caries detection. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Enamel Caries Detection and Diagnosis: An Analysis of Systematic Reviews. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Performance of DIAGNOdent for detection and quantification of smooth-surface caries in primary teeth. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of a novel caries detecting oral rinse. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

In vitro study of the diagnostic performance of the Spectra Caries Detection Aid. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The diagnostic efficacy of quantitative light-induced fluorescence in detection of dental caries of primary teeth. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

In vitro evaluation of the Spectra early caries detection system. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Quantitative light fluorescence: a technology for early monitoring of the caries process. [2015]

11. India pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Visual, Tactile Method, Caries Detector Dye, and Laser Fluorescence in Removal of Dental Caries and Confirmation by Culture and Polymerase Chain Reaction: An In Vivo Study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Impact of interocclusal contacts on infrared laser fluorescence in pits of sound first permanent molars in children. [2016]