Proximal Dental CariesNCT03923192
Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.
A study testing Vistacam and Bitewing radiograph in people with Proximal 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 the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Proximal Dental Caries
- What is being tested?
- Vistacam and Bitewing radiograph
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Aug 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged from 18 to 40 years.
- No gender restriction.
- Patients should have an acceptable oral hygiene level.
- Patients must have at least one posterior proximal caries
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease.
- Heavy bruxism or a traumatic occlusion.
- Acute or chronic dental infection.
- Pregnant or breastfeeding women.
- Patients with posterior restorations on molars or premolars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Validity of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions: Diagnostic Accuracy Study.
The aim of this study is to evaluate the Clinical performance of the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.
- Conditions
- Proximal Dental Caries
- Being tested
- Vistacam, Bitewing radiograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VistacamDevice
device for early proximal caries detection
Bitewing radiographRadiation
radiograph for proximal caries detection
| Study group | Role | What they receive |
|---|---|---|
| ICDAS II | Other | Visual tactile examination based on ICDASII scoring system Receives: Device: Vistacam; Radiation: Bitewing radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries
hidden proximal caries
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 posted22 Apr 2019
- Study start1 May 2020
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal 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
- Not applicable
- Intervention model
- Single group
- Model description
- screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel Fattah Mahmoud Edrees, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923192
- Sponsor's protocol ID
- 2411
- Status last verified
- Aug 2021
- First submitted
- 17 Apr 2019
- Last updated
- 16 Aug 2021
- 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 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Validity of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions: Diagnostic Accuracy Study.
- ClinicalTrials.gov ID
- NCT03923192
- Acronym / sponsor ID
- 2411
- Conditions
- Proximal Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 22 Apr 2019 (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 the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .
| Arm | Type | Receives |
|---|---|---|
| ICDAS II | Other | Device: Vistacam, Radiation: Bitewing radiographVisual tactile examination based on ICDASII scoring system |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged from 18 to 40 years.
- No gender restriction.
- Patients should have an acceptable oral hygiene level.
- Patients must have at least one posterior proximal caries
Key exclusion criteria (6 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease.
- Heavy bruxism or a traumatic occlusion.
- Acute or chronic dental infection.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Vistacamdevice for early proximal caries detection | Device | ICDAS II |
| Bitewing radiographradiograph for proximal caries detection | Radiation | ICDAS II |
Primary outcome
dental caries
Time frame: through study completion, an average of 1 year
hidden proximal caries
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vistacam and Bitewing radiograph in people with Proximal 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 6 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: finished, as of the sponsor's last update on 16 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 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?
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 16 Aug 2021.