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Completed

NCT Number: NCT05919576

Near Infrared Technology for the Detection of Proximal Caries

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

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Faculty of Dentistry

Istanbul, 34854, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of premolar and molar tooth
  • Having an appointment for restorative treatment

Exclusion criteria

  • Restored proximal surfaces
  • Full mouth crowns and removable dental prothesis

Treatment and study plan

Near Infrared Imaging

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.

Primary outcomes

  1. VTM GROUP (Visual-tactile examination)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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