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OpenTrials
Completed

NCT Number: NCT05127356

Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

About this study

This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Non cavitated white spot lesions.
  • Patient compliance

Exclusion criteria

  • Cavitated lesions.
  • Medically compromised patients.
  • Enrollment in another clinical trials.

Treatment and study plan

DIAGNOdent

Device

Laser fluorescence device

ICDAS II

Diagnostic Test

International Caries Detection and Assessment System (ICDAS II)

Primary outcomes

  1. Diagnostic accuracy

    Time frame: Immediate (cross-sectional)

    Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2021
Registry last updated
May 31, 2022

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.

Published trials that share one or more normalized conditions with this study.