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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Dental Caries

Intervention / Treatment
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* Diagnostic Test: ICDAS II
* Device: CariScan Pro
* Radiation: Digital Radiograpgy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cariescan pro<br>device for early caries detection | Device: CariScan Pro<br>* Device for early caries detection<br>Radiation: Digital Radiograpgy<br>* Device for digital x-ray imaging<br>|
| Experimental: ICDAS II<br>Index for caries detection | Diagnostic Test: ICDAS II<br>* Index for caries detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Caries | primary occlusal caries | slow study completion in average of 1 year |