NCT07342595

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Caries AssessmentCaries; DentinCaries; Initial

Keywords

Caries detectionnear-infrared lightclinical performance

Outcome Measures

Primary Outcomes (1)

  • Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability.

    From the enrollment at four weeks.

Study Arms (1)

intraoral scan

OTHER
Diagnostic Test: intraoral scan with integrated caries detection tool

Interventions

intraoral scan with integrated caries detection toolDIAGNOSTIC_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.

intraoral scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich - Center for Dental Medicine

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

  • Albert Mehl, Prof. Dr. Dr.

    University of Zurich, Center for Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Buhl, Dr.

CONTACT

+41 44 634 34 03jenny.buhl@zzm.uzh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Dr.

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 15, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The ethics application, which has already been approved, contains clear provisions on data protection. There is no provision for data to be passed on; accordingly, the investigators must protect all personal data and may not pass it on to third parties.

Locations

CH(1)