Evaluation of Radiation-Free Caries Detection Integrated Into Intraoral Scanners Compared With Conventional Diagnostic Methods
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: intraoral scan with integrated caries detection tool.
- Who it may be relevant to
- Registry conditions: Caries Assessment, Caries; Dentin, Caries; Initial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Performance of an Intraoral Scanner With Integrated Caries Detection
Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- University of Zurich - Center for Dental Medicine — Zurich
Identifiers
NCT: NCT07342595 · 2025-01988