Caries,DentalNCT05919576
Near Infrared Technology for the Detection of Proximal Caries
An observational study of Caries,Dental, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries. Read more about this study
- Who is it for?
- Ages 14 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Near infrared imaging
- Type of treatment
- Medical device
- How many people
- 639 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2022to 29 Aug 2022
- 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 14 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients who have treatment appointments at Marmara University Faculty of Dentistry, Department of Restorative Dentistry
Who may be able to join
- Presence of premolar and molar tooth
- Having an appointment for restorative treatment
Who cannot join
- Restored proximal surfaces
- Full mouth crowns and removable dental prothesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, 34854
About this study
Official title: The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries
This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.
Read the detailed description
A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of premolars and molars were examined. Results were scored for 4 different examination methods; intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for comparison between the methods. The Kappa Test was used to examine the agreement between two methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement between more than two methods. The analysis results are presented as frequency(percentage).The significance level was considered p<0.05.
- Conditions
- Caries,Dental
- Being tested
- Near infrared imaging
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near infrared imagingDevice
In the study, all volunteers are recorded with the itero Element 5D by activating the NIRI mode. The recording method does not involve ionizing radiation. 850 nm wavelength beams are used.
| Study group | Role | What they receive |
|---|---|---|
| Visual-Tactile method (VTM) | In patients who come for treatment and have a prior appointment, an intraoral examination is performed using visual and tactile examination methods. A total of 639 proximal surfaces of 22 patients are examined by investigators using the visual-tactile method. | |
| Bitewing Radiography (BTW) | Bitewing radiographs available in the hospital system of patients who come to their appointment for treatment are examined. A total 639 proximal surface of 22 patient examined by investigators using bitewing radiography. | |
| Near-infrared imaging Technology (NIRI) | A total 639 proximal surface of 22 patient examined by using the NIRI feature of an intraoral scanner. Patients who came for restorative treatment were asked whether they volunteered in our study. An informed consent form was signed, and then lower and upper jaw scans were made by investigators. Receives: Device: Near infrared imaging | |
| Panoramic radiography (PR) | Panoramic radiographs available in the hospital system of patients who come to their appointment for treatment are examined. A total 639 proximal surface of 22 patient examined by using panoramic radiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTM GROUP (Visual-tactile examination)
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Measured: 08.08.2022 - 22.08.2022
Bitewing Radiography
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Measured: 08.08.2022-22.08.2022
Panoramic Radiography
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Measured: 08.08.2022-22.08.2022
NIRI (Near infrared Imaging Technology)
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Measured: 08.08.2022-22.08.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start8 Aug 2022
- Primary completion22 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919576
- Sponsor's protocol ID
- ozlemkanar
- Status last verified
- Jun 2023
- First submitted
- 5 Apr 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries
- ClinicalTrials.gov ID
- NCT05919576
- Acronym / sponsor ID
- ozlemkanar
- Conditions
- Caries,Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 26 Jun 2023 (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.
This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.
Detailed description
A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of premolars and molars were examined. Results were scored for 4 different examination methods; intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for comparison between the methods. The Kappa Test was used to examine the agreement between two methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement between more than two methods. The analysis results are presented as frequency(percentage).The significance level was considered p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Visual-Tactile method (VTM) | – | –In patients who come for treatment and have a prior appointment, an intraoral examination is performed using visual and tactile examination methods. A total of 639 proximal surfaces of 22 patients are examined by investigators using the visual-tactile method. |
| Bitewing Radiography (BTW) | – | –Bitewing radiographs available in the hospital system of patients who come to their appointment for treatment are examined. A total 639 proximal surface of 22 patient examined by investigators using bitewing radiography. |
| Near-infrared imaging Technology (NIRI) | – | Device: Near infrared imagingA total 639 proximal surface of 22 patient examined by using the NIRI feature of an intraoral scanner. Patients who came for restorative treatment were asked whether they volunteered in our study. An informed consent form was signed, and then lower and upper jaw scans were made by investigators. |
| Panoramic radiography (PR) | – | –Panoramic radiographs available in the hospital system of patients who come to their appointment for treatment are examined. A total 639 proximal surface of 22 patient examined by using panoramic radiography. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients who have treatment appointments at Marmara University Faculty of Dentistry, Department of Restorative Dentistry
Key inclusion criteria (2 listed)
- Presence of premolar and molar tooth
- Having an appointment for restorative treatment
Key exclusion criteria (2 listed)
- Restored proximal surfaces
- Full mouth crowns and removable dental prothesis
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 |
|---|---|---|
| Near infrared imagingIn the study, all volunteers are recorded with the itero Element 5D by activating the NIRI mode. The recording method does not involve ionizing radiation. 850 nm wavelength beams are used. | Device | Near-infrared imaging Technology (NIRI) |
Primary outcome
VTM GROUP (Visual-tactile examination)
Time frame: 08.08.2022 - 22.08.2022
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Bitewing Radiography
Time frame: 08.08.2022-22.08.2022
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
Panoramic Radiography
Time frame: 08.08.2022-22.08.2022
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
NIRI (Near infrared Imaging Technology)
Time frame: 08.08.2022-22.08.2022
Surface codes: Sound surface (0), Enamel lesion (1), Lesions involving DEJ (2). A total of at least 150 surfaces are expected to be examined
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 26 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Caries,Dental
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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?
An observational study of Caries,Dental, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 26 Jun 2023. 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 Turkey (Türkiye). 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?
VTM GROUP (Visual-tactile examination) (time frame: 08.08.2022 - 22.08.2022). The study lists 4 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 26 Jun 2023.