Caries,DentalNCT06162182
Comparative Evaluation of an Electrical Impedance Device Versus Digital Radiography in Estimation of Remaining Dentin Thickness
A study testing electrical impedance device, and Reference test: Digital Radiographic examination in people with Caries,Dental and Deep Caries, run by Rawda Hesham Abd ElAziz at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Deep Caries
- What is being tested?
- electrical impedance device, and Reference test: Digital Radiographic examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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)
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.
- Conditions
- Caries,Dental, Deep Caries
- Being tested
- electrical impedance device,, Reference test: Digital Radiographic examination
- Keywords
- electrical impedance device (prepometer), digital radiography, remaining dentin thickness
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance device,Diagnostic test
Also called Prepometer
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 examinationDiagnostic test
A digital periapical radiograph using paralleling technique was taken
| Study group | Role | What they receive |
|---|---|---|
| Reference test: Radiographic examination | Experimental | Not described Receives: Diagnostic Test: Reference test: Digital Radiographic examination |
| Index test: electrical impedance device, Prepometer | Experimental | Not described Receives: Diagnostic Test: electrical impedance device, |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of the two devices
Level of agreement between the digital radiograph and the device in measurement of remaining dentin thickness
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawda Hesham Abd ElAziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawda Hesham Abd ElAziz, Cairo University
- Investigators
- Rawda Hesham Abd ElAziz, PhD, Principal investigator, Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162182
- Sponsor's protocol ID
- CEBD 4/2023
- Status last verified
- Dec 2023
- First submitted
- 14 Nov 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17284915
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06162182
- Acronym / sponsor ID
- CEBD 4/2023
- Conditions
- Caries,Dental, Deep Caries
- Keywords
- electrical impedance device (prepometer), digital radiography, remaining dentin thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Rawda Hesham Abd ElAzizUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference test: Radiographic examination | Experimental | Diagnostic Test: Reference test: Digital Radiographic examination |
| Index test: electrical impedance device, Prepometer | Experimental | Diagnostic Test: electrical impedance device, |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical impedance device,Also: PrepometerThe 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. | Diagnostic test | Index test: electrical impedance device, Prepometer |
| Reference test: Digital Radiographic examinationA digital periapical radiograph using paralleling technique was taken | Diagnostic test | Reference test: Radiographic examination |
Primary outcome
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
1 secondary outcome
Patients satisfaction between two devices
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Background: PubMed 17284915Krause 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rawda Hesham Abd ElAziz, PhD principal investigator
Lecturer, Conservative dentistry department, Faculty of Dentistry, Cairo University.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical impedance device, and Reference test: Digital Radiographic examination in people with Caries,Dental and Deep Caries, run by Rawda Hesham Abd ElAziz at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of the two devices (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.