Dental Caries (Diagnosis)NCT06790485
In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries
An observational study of Dental Caries (Diagnosis), run by Cairo University at 1 site in Egypt.
Trial summary
The diagnosis of non-cavitated occlusal caries is considered problematic and still a challenge for dental professionals. It affects 60-90% of schoolchildren and adults.Clinically, caries commonly is performed by methods of visual examination and subjective assessments of, translucency, color and dental hardness, as… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Dental Caries (Diagnosis)
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2024to 24 Nov 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients will be recruited by researcher according to the eligibility criteria from clinic of conservative dentistry department in Faculty of Dentistry in The British University in Egypt, where there is a continuous and high patient flow
Who may be able to join
- Patients aged from 21 to 50 years.
- Patient at least has one posterior pits and fissure occlusal caries.
- No gender restriction
- Co-operative patients who signed the informed consent.
- Good general health
- Acceptable oral health
Who cannot join
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
- Heavy smoking.
Show all 9Show fewer
- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or temporomandibular joint disorders
Trial locations and contacts
1 site in 1 country.
About this study
The diagnosis of non-cavitated occlusal caries is considered problematic and still a challenge for dental professionals. It affects 60-90% of schoolchildren and adults.Clinically, caries commonly is performed by methods of visual examination and subjective assessments of, translucency, color and dental hardness, as well as by means of radiographic imaging. These methods, however, show low sensitivity for occlusal caries detection.Some of these methods are light based fluorescence devices taking the advantages of the fluorescence properties of the hard tissues of the tooth as there is a difference in fluorescence observed in sound and demineralized dental tissues.Other methods based on electrical impedance has been used. These devices aimed to employ the AC Impedance Spectroscopy Technique (ACIST) In order to record variations in mineral density throughout the tooth, not just the surface, ACIST sends a low amplitude microamp current from the sensor tip contact through the pulp, dentin, and enamel.Hence, a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) and impedance spectroscopy based device (CariescanPRO) in comparison with the visual examination and digital radiography in detection of initial pits and fissures caries.
- Conditions
- Dental Caries (Diagnosis)
- Medical subject headings
- Dental Caries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient with initial occlusal caries | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary occlusal caries
posterior tooth with occlusal discoloration
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start20 Aug 2024
- Primary completion24 Oct 2024
- Study completion24 Nov 2024
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 Dental Caries (Diagnosis)Studies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 7 Days
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
- NCT06790485
- Sponsor's protocol ID
- 24-058
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Edrees A, Hassanein O, Shaalan O, Yassen A. Accuracy of high definition near infrared transillumination camera in detection of hidden proximal caries. J Clin Exp Dent. 2023 Jan 1;15(1):e1-e8. doi: 10.4317/jced.59413. eCollection 2023 Jan.
PubMed 36755680
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Vivo Validation of Novel Diagnostic Devices Versus Visual ICDAS-II Criteria in Detection of Early Occlusal Caries
- ClinicalTrials.gov ID
- NCT06790485
- Acronym / sponsor ID
- 24-058
- Conditions
- Dental Caries (Diagnosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 24 Jan 2025 (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 diagnosis of non-cavitated occlusal caries is considered problematic and still a challenge for dental professionals. It affects 60-90% of schoolchildren and adults.Clinically, caries commonly is performed by methods of visual examination and subjective assessments of, translucency, color and dental hardness, as well as by means of radiographic imaging. These methods, however, show low sensitivity for occlusal caries detection.Some of these methods are light based fluorescence devices taking the advantages of the fluorescence properties of the hard tissues of the tooth as there is a difference in fluorescence observed in sound and demineralized dental tissues.Other methods based on electrical impedance has been used. These devices aimed to employ the AC Impedance Spectroscopy Technique (ACIST) In order to record variations in mineral density throughout the tooth, not just the surface, ACIST sends a low amplitude microamp current from the sensor tip contact through the pulp, dentin, and enamel.Hence, a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) and impedance spectroscopy based device (CariescanPRO) in comparison with the visual examination and digital radiography in detection of initial pits and fissures caries.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with initial occlusal caries | – | – |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients will be recruited by researcher according to the eligibility criteria from clinic of conservative dentistry department in Faculty of Dentistry in The British University in Egypt, where there is a continuous and high patient flow
Key inclusion criteria (6 listed)
- Patients aged from 21 to 50 years.
Key exclusion criteria (9 listed)
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary occlusal caries
Time frame: 1 week
posterior tooth with occlusal discoloration
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 24 Jan 2025.
- Results publication: PubMed 36755680Edrees A, Hassanein O, Shaalan O, Yassen A. Accuracy of high definition near infrared transillumination camera in detection of hidden proximal caries. J Clin Exp Dent. 2023 Jan 1;15(1):e1-e8. doi: 10.4317/jced.59413. eCollection 2023 Jan.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Caries (Diagnosis)
Recruiting
Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools
Periodontitis, Gingivitis
RecruitingObservational study
Assessment of Dental Pathologies Using Digital Tools
Dental Caries (Diagnosis), Dental Plaque (Diagnosis)
RecruitingObservational study
Diagnostic Performance and Children's Acceptance of Near-Infrared Light Transillumination and Bitewing Radiographs for Detecting Proximal Cavitation in Primary Molars of Patients Aged 4 to 10 Years
Dental Caries (Diagnosis), Diagnostic Imaging
Not yet recruiting
Evaluation of the Success Rate of Pulpotomy Versus to Root Canal Therapy in Management of Mature First Permanent Molars With Irreversible Pulpitis
Irreversible Pulpitis (Toothache), Dental Caries (Diagnosis)
Not yet recruitingObservational study
Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries
Dental Caries (Diagnosis), Dental Plaque (Diagnosis)
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?
An observational study of Dental Caries (Diagnosis), 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 6 inclusion and 9 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 24 Jan 2025. 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?
primary occlusal caries (time frame: 1 week). 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 NCT06790485, 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 24 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.