Skip to content

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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04438252
Enrollment
166
Registered
2020-06-18
Start date
2020-09-30
Completion date
2021-09-01
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Brief 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.

Detailed 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).

Interventions

DIAGNOSTIC_TESTICDAS II

Index for caries detection

DEVICECariScan Pro

Device for early caries detection

RADIATIONDigital Radiograpgy

Device for digital x-ray imaging

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dental Cariesslow study completion in average of 1 yearprimary occlusal caries

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026