Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection
NCT ID: NCT04748913
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-11-09
2022-11-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of Near-infrared Light Transillumination for Interproximal Enamel Caries Detection
NCT02657538
The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth
NCT06276959
Diagnostic Ability of Near Infrared Transillumination Detecting Interproximal Caries as Compared to Conventional Bitewing Radiographs
NCT05362461
Diagnostic Performance and Children's Acceptance of Near-Infrared Light Transillumination and Bitewing Radiographs for Detecting Proximal Cavitation in Primary Molars of Patients Aged 4 to 10 Years
NCT07041164
Is DIAGNOcam Comparable to Bitewing Radiographs as a Diagnostic Method for Approximal Caries in Primary Teeth?
NCT03181711
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No intervention
No interventions assigned to this group
Remineralization
Radiographic examination
Standardized bitewing radiographs will be performed by the principal investigator
Scanning with DIAGNOcam
The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device
Scan with DIAGNOcam and Indocyanine
One the dye has been applied, a new series of images will be taken with Diagnocam
Visual-tactile exploration with separation
The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiographic examination
Standardized bitewing radiographs will be performed by the principal investigator
Scanning with DIAGNOcam
The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device
Scan with DIAGNOcam and Indocyanine
One the dye has been applied, a new series of images will be taken with Diagnocam
Visual-tactile exploration with separation
The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Rey Juan Carlos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Santiago Miguel de Vega Calleja
Principal investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Santiago De Vega Calleja
Alcorcón, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Universidad Rey Juan Carlos
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.