Near Infrared Technology for the Detection of Proximal Caries

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT05919576
Collaborator
(none)
639
1
21
926.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Near infrared imaging

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

Study Type:
Observational
Actual Enrollment :
639 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Effectiveness of an Intraoral Scanner With Near-infrared Imaging (Transillumination) Technology for the Detection of Proximal Caries
Actual Study Start Date :
Aug 8, 2022
Actual Primary Completion Date :
Aug 22, 2022
Actual Study Completion Date :
Aug 29, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

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.

Outcome Measures

Primary Outcome Measures

  1. VTM GROUP (Visual-tactile examination) [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

  2. Bitewing Radiography [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

  3. Panoramic Radiography [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

  4. NIRI (Near infrared Imaging Technology) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Faculty of Dentistry Istanbul Turkey 34854

Sponsors and Collaborators

  • Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT05919576
Other Study ID Numbers:
  • ozlemkanar
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023