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

Albert Mehl

Status: Begins enrollment in 1 month

Conditions: Caries; Initial; Caries Assessment; Caries; Dentin

Treatments: Diagnostic Test: intraoral scan with integrated caries detection tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07342595

2025-01988

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All genders, minimum age for participation is 18 years
• Presence of a tooth, that is already scheduled for extraction (indication for extraction diagnosed during the normal clinical service independently of this study by a qualified dentist)
• Availability of a radiograph (X-ray) showing the tooth to be extracted along with adjacent teeth
• Signed informed consent after a comprehensive explanation of the study is available

Exclusion criteria

• participants under the age of 18
• Addicts or participants with impaired cognitive abilities that do not allow the participant to assess the scope of the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

intraoral scan

Other group

Treatment:

Diagnostic Test: intraoral scan with integrated caries detection tool