Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919576
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-04-05
Brief Title:
Near Infrared Technology for the Detection of Proximal Caries
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effectiveness of an Intraoral Scanner With Near-infrared Imaging Transillumination Technology for the Detection of Proximal Caries
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 0no caries 1early enamel lesionEEL 2lesion 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 frequencypercentageThe significance level was considered p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None