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

NCT ID: NCT07342595

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Caries Assessment Caries; Dentin Caries; Initial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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intraoral scan

Group Type OTHER

intraoral scan with integrated caries detection tool

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Albert Mehl

OTHER

Sponsor Role lead

Responsible Party

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Albert Mehl

Prof. Dr. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Albert Mehl, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Center for Dental Medicine

Locations

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University of Zurich - Center for Dental Medicine

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Jenny Buhl, Dr.

Role: CONTACT

+41 44 634 34 03

Facility Contacts

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Jenny Buhl, Dr.

Role: primary

+41 44 634 34 03

Other Identifiers

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2025-01988

Identifier Type: -

Identifier Source: org_study_id

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