Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

Completed

• Conditions: Caries; Initial
• Interventions: Diagnostic Test: ICDAS II; Device: DIAGNOdent

• Registration Number: NCT05127356
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-19
• Study Start: 2022-02-01
• Primary Completion: 2022-04-30
• Status Verified: 2022-05
• Study Completion: 2022-05-05
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• Non cavitated white spot lesions.
• Patient compliance

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Visual examination	ICDAS II	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.
Laser fluorescence	DIAGNOdent	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, El Manial, Egypt