Caries AssessmentNCT07342595
Evaluation of Radiation-Free Caries Detection Integrated Into Intraoral Scanners Compared With Conventional Diagnostic Methods
A study testing intraoral scan with integrated caries detection tool in people with Caries Assessment and Caries; Dentin, run by Albert Mehl at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries Assessment, Caries; Dentin, Caries; Initial
- What is being tested?
- intraoral scan with integrated caries detection tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University of Zurich - Center for Dental Medicine
Zurich, Canton of Zurich, 8032
Jenny Buhl, Dr., +41 44 634 34 03, jenny.buhl@zzm.uzh.ch
About this study
Official title: Clinical Performance of an Intraoral Scanner With Integrated Caries Detection
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:
Read more
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.
- Conditions
- Caries Assessment, Caries; Dentin, Caries; Initial
- Being tested
- intraoral scan with integrated caries detection tool
- Keywords
- Caries detection, near-infrared light, clinical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| intraoral scan | Other | Not described Receives: Diagnostic Test: intraoral scan with integrated caries detection tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the caries detection tool, integrated in intraoral scanning system in terms of sensitivity, specificity and reliability.
Measured: From the enrollment at four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Mehl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albert Mehl, University of Zurich
- Investigators
- Albert Mehl, Prof. Dr. Dr., Principal investigator, University of Zurich, Center for Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342595
- Sponsor's protocol ID
- 2025-01988
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of an Intraoral Scanner With Integrated Caries Detection
- ClinicalTrials.gov ID
- NCT07342595
- Acronym / sponsor ID
- 2025-01988
- Conditions
- Caries Assessment, Caries; Dentin, Caries; Initial
- Keywords
- Caries detection, near-infrared light, clinical performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Albert MehlUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoral scan | Other | Diagnostic Test: intraoral scan with integrated caries detection tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoral scan with integrated caries detection toolThe 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. | Diagnostic test | intraoral scan |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. 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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Dental Caries, Early Childhood Caries (ECC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Mehl, Prof. Dr. Dr. principal investigator
University of Zurich, Center for Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoral scan with integrated caries detection tool in people with Caries Assessment and Caries; Dentin, run by Albert Mehl at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Buhl, Dr. (+41 44 634 34 03, jenny.buhl@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.