Near Infrared Technology for the Detection of Proximal Caries

NCT ID: NCT05919576

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

639 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-08

Study Completion Date

2022-08-29

Brief Summary

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

Detailed Description

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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

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Caries,Dental

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

Near infrared imaging

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marmara University Faculty of Dentistry

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ozlemkanar

Identifier Type: -

Identifier Source: org_study_id

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