Comparative Evaluation of an Electrical Impedance Device Versus Digital Radiography in Estimation of Remaining Dentin Thickness

Comparative Evaluation of an Electrical Impedance Device Versus Digital Radiography in Estimation of Remaining Dentin Thickness in Carious Posterior Permanent Teeth (Diagnostic Accuracy Trial)

The research question was that in patients with carious posterior permanent teeth, would the electrical impedance device be as valid as digital radiography in estimation of remaining dentin thickness? The proposed hypothesis was null.

Study Overview

• Status: Active, not recruiting
• Conditions: Deep Caries; Caries,Dental
• Intervention / Treatment: Diagnostic test: Reference test: Digital Radiographic examination; Diagnostic test: electrical impedance device,

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University
  • Cairo, Egypt, 11331
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants eligible for this study were those aged from 18 y to 28 y,
• willing to join the study
• with clinically detectable occlusal or proximal carious vital permanent molar teeth with closed apex and healthy periodontal supporting.
• The minimum extension of the carious cavity should be at least 1 mm in width to accommodate with the probe of the prepometer

Exclusion Criteria:

• Excluded participants were those with poor oral hygiene,
• severe medical complications,
• showing signs and symptoms of irreversible or necrotic pulp pathology also when the affected tooth was with extended buccal or lingual caries, extending clinically beyond ¼ dentin thickness or previously restored.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference test: Radiographic examination	Diagnostic test: Reference test: Digital Radiographic examination; A digital periapical radiograph using paralleling technique was taken
Experimental: Index test: electrical impedance device, Prepometer	Diagnostic test: electrical impedance device,; The electrical resistance of the residual dentine underneath each measurement point was determined between an electrode and the crown pulp (Prepometer, Hager & Werken, Duisburg, Germany). Assigning the electrical resistance of the dentin. high values are considered to represent more residual dentine than low values.; Other Names: Prepometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validity of the two devices	Level of agreement between the digital radiograph and the device in measurement of remaining dentin thickness	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients satisfaction between two devices	By visual analogue scale Visual Analog Scale (VAS) which is a 100 mm straight horizontal line with the left end indicating •not at all satisfied- and the right end "very satisfied.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Rawda Hesham Abd ElAziz
• Investigators: Principal Investigator: Rawda Hesham Abd ElAziz, PhD, Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Publications and helpful links

General Publications

• Krause F, Braun A, Eberhard J, Jepsen S. Laser fluorescence measurements compared to electrical resistance of residual dentine in excavated cavities in vivo. Caries Res. 2007;41(2):135-40. doi: 10.1159/000098047.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: electrical impedance device (prepometer); digital radiography; remaining dentin thickness
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CEBD 4/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No