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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intraoral scan | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability. | From the enrollment at four weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Buhl, Dr. | Contact | +41 44 634 34 03 | jenny.buhl@zzm.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Albert Mehl, Prof. Dr. Dr. | University of Zurich, Center for Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich - Center for Dental Medicine | Zurich | Canton of Zurich | 8032 | Switzerland |
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.
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