Near Infrared Technology for the Detection of Proximal Caries

NCT05919576 | Completed FDA Device

• 1 other identifier: ozlemkanar
• Study Type: observational
• Target: 639
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effectiveness of an intraoral scanner with near-infrared imaging (NIRI) for the diagnosis of proximal caries.

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  08.08.2022-22.08.2022

Study Arms (4)

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.

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.

Interventions

Near infrared imaging DEVICE

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.

Near-infrared imaging Technology (NIRI)

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who have treatment appointments at Marmara University Faculty of Dentistry, Department of Restorative Dentistry

You may qualify if:

• Presence of premolar and molar tooth
• Having an appointment for restorative treatment

You may not qualify if:

• Restored proximal surfaces
• Full mouth crowns and removable dental prothesis

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 26, 2023
• Study Start: August 8, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 29, 2022
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)