NCT07342595

Evaluation of Radiation-Free Caries Detection Integrated Into Intraoral Scanners Compared With Conventional Diagnostic Methods

Clinical Performance of an Intraoral Scanner With Integrated Caries Detection

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Albert Mehl · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to evaluate if an intraoral scanning device with an integrated radiation-free caries detection tool (near-infrared light) can detect early tooth decay. The main questions it aims to answer are: Can the tool find tooth decay as accurately as traditional visual and X-ray examinations? How reliable is the tool when used by different dentists? Participants will: * Have one tooth scheduled for extraction. This tooth and its adjacent teeth need to be examined before the extraction by using the intraoral scanner with the caries detection tool, which takes about 5 extra minutes. Those results will be compared to the standard dental examination, including visual inspection and X-rays. * Allow investigators to check the extracted tooth and the neighboring teeth directly after extraction to see if any carious lesion is visible. This study does not involve any drugs or invasive procedures beyond the planned tooth extraction, and participants will not be exposed to extra radiation. The results will help dentists detect tooth decay, which may allow less invasive treatments and better prevention.

Conditions

• Caries Assessment
• Caries; Dentin
• Caries; Initial

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	intraoral scan with integrated caries detection tool	The intervention in this study is the addition of a non-invasive intraoral scan of the tooth scheduled for extraction and its adjacent teeth using the iTero Lumina device. This scan is CE-certified, performed according to the manufacturer's instructions, takes approximately 5 minutes, involves no radiation, and does not change the standard dental treatment. All other procedures, including visual examination, radiographs, and tooth extraction, are part of routine care and are not affected by the study.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study