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Clinical Trials/NCT06162182
NCT06162182Active, not recruitingNot Applicable

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

Rawda Hesham Abd ElAziz3 sites in 1 country67 target enrollmentStarted: February 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
67
Locations
3
Primary Endpoint
validity of the two devices

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Masking Description

The assessors will not be blind about the type of intervention/control assessment methods due to different application methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period

Eligibility Criteria

Ages
12 Years to 25 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

validity of the two devices

Time Frame: Through study completion, an average of 1 year

Level of agreement between the digital radiograph and the device in measurement of remaining dentin thickness

Secondary Outcomes

  • Patients satisfaction between two devices(Through study completion, an average of 1 year)

Investigators

Sponsor
Rawda Hesham Abd ElAziz
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rawda Hesham Abd ElAziz

Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Cairo University

Study Sites (3)

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