Dental CariesNCT06276959
The Effectiveness of iTero Element 5D NIRI System in Early Proximal Caries Detection in Permanent Teeth
An observational study of Dental Caries, run by West China College of Stomatology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Dental Caries
- What is being tested?
- intraoral scanning, clinical oral examination and cone-beam computed tomography
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Mar 2025
- Phase
- Observational
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients who underwent orthodontic treatment at the West China School of Stomatology.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, 610041
Zhihe Zhao, Doctor, +86 139 8188 1666, zhzhao@scu.edu.cn
About this study
Official title: Comparison of Near-infrared Imaging With Cone Beam Computed Tomography for Proximal Caries Detection in Permanent Dentition: An in Vivo Study.
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.
- Conditions
- Dental Caries
- Being tested
- intraoral scanning, clinical oral examination, cone-beam computed tomography
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoral scanningDiagnostic test
The patients underwent intraoral scanning using an iTero Element 5D imaging system (Align Technology, San Jose, CA, USA). This imaging system uses near-infrared light with a wavelength of 850 nm and provides multiple layers of data in a single scan, including a three-dimensional (3D) model, two-dimensional (2D) color images, and NIRI mapped to the 3D model
clinical oral examinationDiagnostic test
Under illumination in the dental unit, a UVE of the proximal surfaces of the patient's entire dentition was conducted by clinicians using a mouth mirror, dental probe, and an air-water syringe. Visual and tactile methods were performed according to the guidelines of the American Dental Association. Clinicians assessed the soundness of the proximal surfaces based on the presence of discoloration, surface alterations, or cavitation.
cone-beam computed tomographyDiagnostic test
All enrolled patients underwent CBCT scans because clear aligner treatment required real root/bone visualization features. We would like to clarify that due to the retrospective cross-sectional nature of this study, the patients involved were not subjected to radiation beyond what was initially necessary for their orthodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| The population with a potential risk of proximal caries. | Not described Receives: Diagnostic Test: intraoral scanning; Diagnostic Test: clinical oral examination; Diagnostic Test: cone-beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive percent agreement
Using CBCT as the reference test, positive percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
Measured: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
negative percent agreement
Using CBCT as the reference test, negative percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
Measured: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
overall percent agreement
Using CBCT as the reference test, overall percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
Measured: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
Secondary outcomes (3)
Proximal caries positive site diagnosed by CBCT
Diagnosis of of carious proximal tooth surfaces identified through CBCT. Specifically, the cross-sectional view showing the deepest caries involvement was used for International Caries Detection and Assessment System (ICDAS) scoring and was categorized into shallow caries, moderate caries (ICDAS 1-2), and deep caries (ICDAS 3-6).
Measured: Immediately following CBCT image interpretation.
Proximal caries positive site diagnosed by near-infrared imaging (NIRI)
Owing to the challenges in applying ICDAS scoring for proximal caries detected using NIRI, the classification was either positive (manifest as bright areas) or negative.
Measured: Immediately following NIRI image interpretation.
Proximal caries positive site diagnosed by unaided visual examination (UVE)
Under illumination in the dental unit, a UVE of the proximal surfaces of the patient's entire dentition was conducted by senior orthodontists using a mouth mirror, dental probe, and an air-water syringe. Visual and tactile methods were performed according to the guidelines of the American Dental Association. Owing to the challenges in applying ICDAS scoring for proximal caries detected using UVE, the classification was either positive (presence of discoloration, surface alterations, or cavitation) or negative.
Measured: Immediately following clinical oral examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China College of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Kai, West China College of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276959
- Sponsor's protocol ID
- WCHSIRB-D-2022-430
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Near-infrared Imaging With Cone Beam Computed Tomography for Proximal Caries Detection in Permanent Dentition: An in Vivo Study.
- ClinicalTrials.gov ID
- NCT06276959
- Acronym / sponsor ID
- WCHSIRB-D-2022-430
- Conditions
- Dental Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- West China College of StomatologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Feb 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The population with a potential risk of proximal caries. | – | Diagnostic Test: intraoral scanning, Diagnostic Test: clinical oral examination, Diagnostic Test: cone-beam computed tomography |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent orthodontic treatment at the West China School of Stomatology.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 scanningThe patients underwent intraoral scanning using an iTero Element 5D imaging system (Align Technology, San Jose, CA, USA). This imaging system uses near-infrared light with a wavelength of 850 nm and provides multiple layers of data in a single scan, including a three-dimensional (3D) model, two-dimensional (2D) color images, and NIRI mapped to the 3D model | Diagnostic test | The population with a potential risk of proximal caries. |
| clinical oral examinationUnder illumination in the dental unit, a UVE of the proximal surfaces of the patient's entire dentition was conducted by clinicians using a mouth mirror, dental probe, and an air-water syringe. Visual and tactile methods were performed according to the guidelines of the American Dental Association. Clinicians assessed the soundness of the proximal surfaces based on the presence of discoloration, surface alterations, or cavitation. | Diagnostic test | The population with a potential risk of proximal caries. |
| cone-beam computed tomographyAll enrolled patients underwent CBCT scans because clear aligner treatment required real root/bone visualization features. We would like to clarify that due to the retrospective cross-sectional nature of this study, the patients involved were not subjected to radiation beyond what was initially necessary for their orthodontic treatment. | Diagnostic test | The population with a potential risk of proximal caries. |
Primary outcome
positive percent agreement
Time frame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
Using CBCT as the reference test, positive percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
negative percent agreement
Time frame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
Using CBCT as the reference test, negative percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
overall percent agreement
Time frame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.
Using CBCT as the reference test, overall percent agreement of NIRI, UVE, and a combination of the two index tests in parallel (PAR) for the detection of proximal caries at different depths and in different tooth locations was evaluated.
3 secondary outcomes
Proximal caries positive site diagnosed by CBCT
Time frame: Immediately following CBCT image interpretation.
Proximal caries positive site diagnosed by near-infrared imaging (NIRI)
Time frame: Immediately following NIRI image interpretation.
Proximal caries positive site diagnosed by unaided visual examination (UVE)
Time frame: Immediately following clinical oral examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
West China Hospital of Stomatology, Sichuan University
Chengdu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by West China College of Stomatology at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive percent agreement (time frame: After the interpretation of CBCT, NIRI, and UVE, an average of 10 months.). The study lists 3 primary outcomes in all. 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 12 Apr 2024.