Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

NCT05127356 | Completed DMC

• 1 other identifier: Diagnodent
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries; Initial

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

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

  Immediate (cross-sectional)

Study Arms (2)

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

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

Interventions

DIAGNOdent DEVICE

Laser fluorescence device

Laser fluorescence

ICDAS II DIAGNOSTIC_TEST

International Caries Detection and Assessment System (ICDAS II)

Visual examination

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non cavitated incipient carious white spot lesions

You may qualify if:

• Non cavitated white spot lesions.
• Patient compliance

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

Location

Study Officials

• Omar O Shaalan, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Conservative Dentistry Department, Faculty of Dentistry

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 19, 2021
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 5, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)