NCT06162182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

November 14, 2023

Last Update Submit

December 6, 2023

Conditions

Caries,DentalDeep Caries

Keywords

electrical impedance device (prepometer)digital radiographyremaining dentin thickness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patients satisfaction between two devices

    Through study completion, an average of 1 year

Study Arms (2)

Reference test: Radiographic examination

EXPERIMENTAL
Diagnostic Test: Reference test: Digital Radiographic examination

Index test: electrical impedance device, Prepometer

EXPERIMENTAL
Diagnostic Test: electrical impedance device,

Interventions

electrical impedance device,DIAGNOSTIC_TEST

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.

Also known as: Prepometer
Index test: electrical impedance device, Prepometer
Reference test: Digital Radiographic examinationDIAGNOSTIC_TEST

A digital periapical radiograph using paralleling technique was taken

Reference test: Radiographic examination

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry

Cairo, 11331, Egypt

Location

Cairo University

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 17284915BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Rawda Hesham Abd ElAziz, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.

Study Record Dates

First Submitted

November 14, 2023

First Posted

December 8, 2023

Study Start

February 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 20, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)