NCT05919576

Near Infrared Technology for the Detection of Proximal Caries

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 639 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 14 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Caries,Dental

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-08
• Primary completion: 2022-08-22
• Completion: 2022-08-29
• First posted: 2023-06-26
• Last updated: 2023-06-26

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study