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NCT05919576 Clinical Trial

Near Infrared Technology for the Detection of Proximal Caries

Caries,Dental Clinical Trial

Official title:
The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05919576
Other study ID # ozlemkanar
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2022
Est. completion date August 29, 2022

Study information
Verified date June 2023
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 639
Est. completion date August 29, 2022
Est. primary completion date August 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 45 Years
Eligibility Inclusion Criteria 1. Presence of premolar and molar tooth 2. Having an appointment for restorative treatment Exclusion Criteria 1. Restored proximal surfaces 2. Full mouth crowns and removable dental prothesis

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Near infrared imaging
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.

Locations
Country Name City State
Turkey Marmara University Faculty of Dentistry Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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