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NCT Number: NCT07342595

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich - Center for Dental Medicine

Zurich, Canton of Zurich, 8032, Switzerland

Location contact

Jenny Buhl, Dr.

CONTACT

[email protected]

+41 44 634 34 03

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intraoral scan with integrated caries detection tool

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.

Primary outcomes

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

    Time frame: From the enrollment at four weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Buhl, Dr.

CONTACT

[email protected]

+41 44 634 34 03

Sponsors and collaborators

Lead sponsor

Albert Mehl

Other

Registry information

Official study title

Clinical Performance of an Intraoral Scanner With Integrated Caries Detection

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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