Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

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

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.

Study Overview

• Status: Completed
• Conditions: Caries; Initial
• Intervention / Treatment: Device: DIAGNOdent; Diagnostic test: ICDAS II

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11553
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non cavitated incipient carious white spot lesions

Description

Inclusion Criteria:

• Non cavitated white spot lesions.
• Patient compliance

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laser fluorescence; DIAGNOdent is a laser fluorescence device that detects and quantify stages of development of incipient carious lesions 0-4 healthy tooth structure; 5-10 Outer half enamel caries; 11-20 Inner half enamel caries; 21+ Dentin caries	Device: DIAGNOdent; Laser fluorescence device
Visual examination; ICDAS II Code 0: Sound tooth surface; Code 1: First visual change in enamel; Code 2:Distinct visual change in enamel when viewed wet; Code 3: Localized enamel breakdown due to caries with no visible dentin; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown; Code 5: Distinct cavity with visible dentin; Code 6: Extensive distinct cavity with visible dentin.	Diagnostic test: ICDAS II; International Caries Detection and Assessment System (ICDAS II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.	Immediate (cross-sectional)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): May 5, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (ACTUAL): November 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Diagnodent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO