Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

Caries; Initial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127356
• Other study ID #: Diagnodent
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: May 5, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: May 5, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Non cavitated white spot lesions.

• Patient compliance

Exclusion Criteria:

• Cavitated lesions.

• Medically compromised patients.

• Enrollment in another clinical trials.

Related Conditions & MeSH terms

• Caries; Initial

Intervention

Device:
• DIAGNOdent
Laser fluorescence device

Diagnostic Test:
• ICDAS II
International Caries Detection and Assessment System (ICDAS II)

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity.	Immediate (cross-sectional)