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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Mehl

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: intraoral scanOther 1 intervention

Trial outcomes

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albert Mehl

Lead sponsor

University of Zurich

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: