Initial Proximal CariesNCT04748913
Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
A study testing Radiographic examination, Scanning with DIAGNOcam and Scan with DIAGNOcam and Indocyanine in people with Initial Proximal Caries, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of the study will be to make a comparison in vivo of the following techniques: DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Initial Proximal Caries
- What is being tested?
- Radiographic examination, Scanning with DIAGNOcam and Scan with DIAGNOcam and Indocyanine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2020to 9 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)
Who cannot join
- estructural abnormalities
- visible clinical cavitation
- restorations on the proximal surfaces
- open contact points
- overlapping structures on the X-ray that prevent a clear view of the proximal area
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study will be to make a comparison in vivo of the following techniques:
DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.
Read more
Methodology:
During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.
- Conditions
- Initial Proximal Caries
- Being tested
- Radiographic examination, Scanning with DIAGNOcam, Scan with DIAGNOcam and Indocyanine, Visual-tactile exploration with separation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic examinationDevice
Standardized bitewing radiographs will be performed by the principal investigator
Scanning with DIAGNOcamDevice
The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device
Scan with DIAGNOcam and IndocyanineDevice
One the dye has been applied, a new series of images will be taken with Diagnocam
Visual-tactile exploration with separationDiagnostic test
The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Remineralization | Other | Not described Receives: Device: Radiographic examination; Device: Scanning with DIAGNOcam; Device: Scan with DIAGNOcam and Indocyanine; Diagnostic Test: Visual-tactile exploration with separation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near infrared transillumination
Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start9 Nov 2020
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Initial Proximal CariesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago Miguel de Vega Calleja, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748913
- Sponsor's protocol ID
- Universidad Rey Juan Carlos
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2021
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
- ClinicalTrials.gov ID
- NCT04748913
- Acronym / sponsor ID
- Universidad Rey Juan Carlos
- Conditions
- Initial Proximal Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 10 Feb 2021 (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 aim of the study will be to make a comparison in vivo of the following techniques:
DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard.
Methodology:
During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Remineralization | Other | Device: Radiographic examination, Device: Scanning with DIAGNOcam, Device: Scan with DIAGNOcam and Indocyanine, Diagnostic Test: Visual-tactile exploration with separation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)
Key exclusion criteria (5 listed)
- estructural abnormalities
- visible clinical cavitation
- restorations on the proximal surfaces
- open contact points
- overlapping structures on the X-ray that prevent a clear view of the proximal area
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 |
|---|---|---|
| Radiographic examinationStandardized bitewing radiographs will be performed by the principal investigator | Device | Remineralization |
| Scanning with DIAGNOcamThe surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device | Device | Remineralization |
| Scan with DIAGNOcam and IndocyanineOne the dye has been applied, a new series of images will be taken with Diagnocam | Device | Remineralization |
| Visual-tactile exploration with separationThe point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator | Diagnostic test | Remineralization |
Primary outcome
Near infrared transillumination
Time frame: 2 years
Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiographic examination, Scanning with DIAGNOcam and Scan with DIAGNOcam and Indocyanine in people with Initial Proximal Caries, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 Aug 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near infrared transillumination (time frame: 2 years). 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 7 Aug 2026.