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

June 17, 2020 updated by: Amr Ramadan Abdelkader, Cairo University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11553
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Olfat ElSayed Hassanien, Doctor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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