Comparing two devices for detecting dental caries
A Pilot Clinical Trial Comparing the Efficacy of Caries Detection With a Novel Caries Detecting Rinse and Existing Diagnostic Tools
This study is testing two different devices to see which one better detects cavities in adults at high risk, including those who use e-cigarettes and those who don’t.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Tufts University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06152081 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the LumiCare™ rinse and QLF Inspektor Pro Imaging in detecting caries progression in patients at the Tufts University School of Dental Medicine. It will also investigate the differences in carious lesion progression between patients who use e-cigarettes/vapes and those who do not. Participants must be adults over 21 with a high risk of caries and specific dental conditions. The study will utilize visual assessments and imaging techniques to gather data on caries detection.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with a high risk of caries and specific dental conditions as outlined in the eligibility criteria.
Not a fit: Patients with low or moderate caries risk or those without clinically detectable carious lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of caries detection and management, leading to better dental health outcomes for patients.
How similar studies have performed: While there have been studies on caries detection methods, the specific comparison of LumiCare™ rinse and QLF Inspektor Pro Imaging is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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
Where this trial is running
Boston, Massachusetts
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Karina Irusa, BDS, MS — Tufts University School of Dental Medicine
- Study coordinator: Karina Irusa, BDS,MS
- Email: dentalresearchadministration@tufts.edu
- Phone: 6176362408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.