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NCT04438252 Clinical Trial

Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions

Dental Caries Clinical Trial

Official title:
Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04438252
Other study ID # 1711
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 2020
Est. completion date September 1, 2021

Study information
Verified date June 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.

Description:

The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 166
Est. completion date September 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria of teeth:

- Posterior teeth with dark shadow on occlusal surface.

- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.

- Intact contact with opposing teeth.

- Teeth with no previous restorations in other surfaces.

Exclusion criteria of the teeth:

- Periapical pathology or signs of pulpal pathology.

- Tooth hypersensitivity.

- Possible prosthodontic restoration of teeth.

- Heavy occlusion and occlusal contacts or history of bruxism.

- Severe periodontal affection.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• ICDAS II
Index for caries detection
Device:
• CariScan Pro
Device for early caries detection
Radiation:
• Digital Radiograpgy
Device for digital x-ray imaging

Locations
Country Name City State
Egypt Faculty Of Dentistry Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dental Caries primary occlusal caries slow study completion in average of 1 year
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