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

Caries,Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06162182
• Other study ID #: CEBD 4/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 67
• Est. completion date: December 20, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Deep Caries
• Dental Caries

Intervention

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.
• Reference test: Digital Radiographic examination
A digital periapical radiograph using paralleling technique was taken

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rawda Hesham Abd ElAziz

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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