UnknownNot Applicable

The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth

China120 participantsStarted 2023-01-01

Plain-language summary

As a new emerging technology for the diagnosis of dental caries, near-infrared imaging requires further research and validation to determine its effectiveness. This study aims to compare near-infrared imaging with cone-beam computed tomography (CBCT) to validate the efficiency of near-infrared imaging in diagnosing proximal caries using large-scale clinical data through retrospective cross-sectional studies.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Permanent dentition * Participants aged 12 and above * Patients who have undergone iTero Element 5D oral scanning, as well as CBCT imaging, intraoral photography, and clinical oral examination within 1 week * CBCT or iTero Element 5D oral scanning indicating proximal caries Exclusion Criteria: The following teeth were excluded: * Third molars * Teeth with gross loss of tooth structure (cavitated carious lesions extending to the occlusal or buccal/lingual surfaces) * Teeth with amalgam fillings and their adjacent teeth * Teeth with crown restorations and their adjacent teeth

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

positive percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

negative percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

overall percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

Trial details

NCT IDNCT06276959

SponsorWest China College of Stomatology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Dental Caries trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

positive percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

negative percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.

overall percent agreement

Timeframe: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.