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

Primary Purpose

Dental Caries

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

ICDAS II

CariScan Pro

Digital Radiograpgy

About this trial

This is an interventional diagnostic trial for Dental Caries

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Faculty Of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cariescan pro

ICDAS II

Arm Description

device for early caries detection

Index for caries detection

Outcomes

Primary Outcome Measures

Dental Caries

primary occlusal caries

Secondary Outcome Measures

Full Information

NCT ID

NCT04438252

First Posted

June 15, 2020

Last Updated

June 17, 2020

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04438252

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2020 (Anticipated)

Primary Completion Date

May 1, 2021 (Anticipated)

Study Completion Date

September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cariescan pro

Arm Type

Experimental

Arm Description

device for early caries detection

Arm Title

ICDAS II

Arm Type

Experimental

Arm Description

Index for caries detection

Intervention Type

Diagnostic Test

Intervention Name(s)

ICDAS II

Intervention Description

Index for caries detection

Intervention Type

Device

Intervention Name(s)

CariScan Pro

Intervention Description

Device for early caries detection

Intervention Type

Radiation

Intervention Name(s)

Digital Radiograpgy

Intervention Description

Device for digital x-ray imaging

Primary Outcome Measure Information:

Title

Dental Caries

Description

primary occlusal caries

Time Frame

slow study completion in average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olfat ElSayed Hassanien, Doctor

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Faculty Of Dentistry

City

Cairo

ZIP/Postal Code

11553

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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