Dental CariesNCT04438252
Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions
A study testing ICDAS II, CariScan Pro and Digital Radiograpgy in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- ICDAS II, CariScan Pro and Digital Radiograpgy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2020to 1 Sep 2021
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Posterior teeth with dark shadow on occlusal surface.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Intact contact with opposing teeth.
- Teeth with no previous restorations in other surfaces.
Who cannot join
- Periapical pathology or signs of pulpal pathology.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.
The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.
Read the detailed description
The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).
- Conditions
- Dental Caries
- Being tested
- ICDAS II, CariScan Pro, Digital Radiograpgy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDAS IIDiagnostic test
Index for caries detection
CariScan ProDevice
Device for early caries detection
Digital RadiograpgyRadiation
Device for digital x-ray imaging
| Study group | Role | What they receive |
|---|---|---|
| Cariescan pro | Experimental | device for early caries detection Receives: Device: CariScan Pro; Radiation: Digital Radiograpgy |
| ICDAS II | Experimental | Index for caries detection Receives: Diagnostic Test: ICDAS II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries
primary occlusal caries
Measured: slow study completion in 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 posted18 Jun 2020
- Study startSep 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ramadan Abdelkader, Cairo University
- Investigators
- Olfat ElSayed Hassanien, Doctor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438252
- Sponsor's protocol ID
- 1711
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reliability of Impedance Spectroscopy (CarieScan PRO) in Comparison With Digital Radiograph and ICDAS-II in Detection of Occlusal Carious Lesions: Diagnostic Accuracy Study.
- ClinicalTrials.gov ID
- NCT04438252
- Acronym / sponsor ID
- 1711
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 18 Jun 2020 (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 aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.
Detailed description
The visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. It has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (Ismail, et al., 2007). In the current study, ICDAS-II was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. In addition, several studies have shown good reproducibility and accuracy of ICDAS-II for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (Gugnani, et al., 2010). Bitewing radiographs are used to determine the depth of caries involvement. Most often, bitewing examination is affiliated with the diagnosis of interproximal caries. It is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (Pitts NB et al., 1991).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariescan pro | Experimental | Device: CariScan Pro, Radiation: Digital Radiograpgydevice for early caries detection |
| ICDAS II | Experimental | Diagnostic Test: ICDAS IIIndex for caries detection |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Posterior teeth with dark shadow on occlusal surface.
- Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
- Intact contact with opposing teeth.
- Teeth with no previous restorations in other surfaces.
Key exclusion criteria (5 listed)
- Periapical pathology or signs of pulpal pathology.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
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 |
|---|---|---|
| ICDAS IIIndex for caries detection | Diagnostic test | ICDAS II |
| CariScan ProDevice for early caries detection | Device | Cariescan pro |
| Digital RadiograpgyDevice for digital x-ray imaging | Radiation | Cariescan pro |
Primary outcome
Dental Caries
Time frame: slow study completion in average of 1 year
primary occlusal caries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
Olfat ElSayed Hassanien, Doctor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICDAS II, CariScan Pro and Digital Radiograpgy in people with Dental Caries, run by Cairo University at 1 site 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 5 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Dental Caries (time frame: slow study completion in average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2020.