Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

NCT ID: NCT05127356

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-05-05

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

Conditions

Caries; Initial

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

DIAGNOdent

Intervention Type: DEVICE

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.

ICDAS II

Intervention Type: DIAGNOSTIC_TEST

International Caries Detection and Assessment System (ICDAS II)

Interventions

DIAGNOdent

Laser fluorescence device

Intervention Type: DEVICE

ICDAS II

International Caries Detection and Assessment System (ICDAS II)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Non cavitated white spot lesions.
• Patient compliance

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omar Osama Shaalan

Lecturer, Conservative Dentistry Department, Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar O Shaalan, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Locations

Faculty of Dentistry, Cairo University

Cairo, El Manial, Egypt

Countries

Egypt

Other Identifiers

Diagnodent

Identifier Type: -

Identifier Source: org_study_id