ConditionNCT05777057
Assessing Accuracy of Kavo Diagnodent
A study testing Diagnodent in people with Condition, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the accuracy of kavodiagondent and compare with digital radiograph (vista scan).the gold standard is light microscope Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Condition
- What is being tested?
- Diagnodent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Nov 2022to 30 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Extracted posterior teeth Visually intact occlusal surfaces or a variety of occlusal carious lesions, but no obvious cavities
- Removal of organic material and stains from the surfaces, the teeth will be immersed in 10% sodium hypochlorite solution for 20 min, followed by rinsing in distilled water for 20 min. The teeth will then stored in saturated thymol solution or formalin.
- The teeth will be arranged in pairs and mounted in plaster blocks.
Who cannot join
- Teeth with deep cavity
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between KAVO DIAGNOdent and Digital Radiography in Occlusal Caries Detection (A Diagnostic Accuracy Study)
This study aims to evaluate the accuracy of kavodiagondent and compare with digital radiograph (vista scan).the gold standard is light microscope
Read the detailed description
Extracted teeth with intial caries (no cavitation)will be used to detect caries. The teeth will be numbered and each of the occlusal surfaces will be measured by DIAGNOdent with a conical probe in accordance with the manufacturer's instructions. The standard value for each individual tooth will be calibrated before each measurement by measuring in a region of sound tissue. The occlusal surfaces will be carefully scanned and measured 3 times when wet, and 3 times after they had been wiped with paper tissues and exposed to air for about 2 min in room temperature. The maximum value from each measurement will be registered and the mean values of the three data under wet and dry conditions, respectively, will be calculated. After an interval of 2 weeks, the procedure will be repeated under identical conditions. All occlusal surfaces will be photographed. The sites with the highest values will be indicated in the photographs in order to identify the location for the second measurement and for subsequent sectioning for light microscope examination.
The teeth will be arranged in pairs and mounted in plaster blocks. Reproducible radiographs will be obtained. This will be done by digital radiography (vista scan sensor). The radiographs will be examined by 4 radiologists. The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth. The following scale was used: 1 = definitely not caries, 2 = probably not Caries, 3 = questionable, 4 = probably caries, and 5 = definitely caries.
After the laser fluorescence measurements had been completed and the digital radiographs had been exposed, the teeth will be removed from the blocks and embedded in plastic. At the sites indicated in the photographs, buccolingual sections approximately 300 µm thick will be taken perpendicular to the occlusal surfaces using a water-cooled saw. The slices will then examined under light microscope. The lesion depth will be scored on a scale from 0 to 4, where 0 = sound, 1 = enamel caries limited to the outer half of the enamel, 2 = enamel caries in the inner half of the enamel, 3 = dentinal caries in the outer half of the dentine, and 4 =dentinal caries in the inner half of the dentine
- Conditions
- Condition
- Being tested
- Diagnodent
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnodentDiagnostic test
using DIAGNDENT depends on the principle that when 655nm wavelength of Diode laser is irradiated on dental surface, intraoral bacteria metabolites will absorb it and then metabolites emit a red fluorescence. The dental surface will reflect this fluorescence and gives number between 0 and 99 on the screen of the DIAGNdent.
| Study group | Role | What they receive |
|---|---|---|
| Extracted teeth | Other | Extracted teeth with intial caries without cavitation is examined by diagnodent and digital imaging and then by light microscope Receives: Diagnostic Test: Diagnodent |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect of occlusal caries
Primary Outcome Measure:
1.To detect of occlusal caries To detect occlusal caries.42 teeth with initial non cavitated caries will be examined by kavodiagondent and then radiographed. The occlusal surfaces will be carefully scanned and measured 3 times when wet, and 3 times after they had been wiped with paper tissues and exposed to air for about 2 min in room temperature.the teeth will be radiographed.The radiographs will be examined by 4 radiologists. The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth. The following scale was used: 1 = definitely not caries, 2 = probably not Caries, 3 = questionable, 4 = probably caries, and 5 = definitely caries.
the light microscope will be used as gold standard.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start16 Nov 2022
- Primary completion16 Nov 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConditionStudies 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
- Extracted teeth are radiographed and examined by diagnodent and then sections are examined under light microscope
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mahmoud Elsayed Said, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777057
- Sponsor's protocol ID
- ORAD 3-3-1
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between KAVO DIAGNOdent and Digital Radiography in Occlusal Caries Detection (A Diagnostic Accuracy Study)
- ClinicalTrials.gov ID
- NCT05777057
- Acronym / sponsor ID
- ORAD 3-3-1
- Conditions
- Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 20 Mar 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.
This study aims to evaluate the accuracy of kavodiagondent and compare with digital radiograph (vista scan).the gold standard is light microscope
Detailed description
Extracted teeth with intial caries (no cavitation)will be used to detect caries. The teeth will be numbered and each of the occlusal surfaces will be measured by DIAGNOdent with a conical probe in accordance with the manufacturer's instructions. The standard value for each individual tooth will be calibrated before each measurement by measuring in a region of sound tissue. The occlusal surfaces will be carefully scanned and measured 3 times when wet, and 3 times after they had been wiped with paper tissues and exposed to air for about 2 min in room temperature. The maximum value from each measurement will be registered and the mean values of the three data under wet and dry conditions, respectively, will be calculated. After an interval of 2 weeks, the procedure will be repeated under identical conditions. All occlusal surfaces will be photographed. The sites with the highest values will be indicated in the photographs in order to identify the location for the second measurement and for subsequent sectioning for light microscope examination.
The teeth will be arranged in pairs and mounted in plaster blocks. Reproducible radiographs will be obtained. This will be done by digital radiography (vista scan sensor). The radiographs will be examined by 4 radiologists. The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth. The following scale was used: 1 = definitely not caries, 2 = probably not Caries, 3 = questionable, 4 = probably caries, and 5 = definitely caries.
After the laser fluorescence measurements had been completed and the digital radiographs had been exposed, the teeth will be removed from the blocks and embedded in plastic. At the sites indicated in the photographs, buccolingual sections approximately 300 µm thick will be taken perpendicular to the occlusal surfaces using a water-cooled saw. The slices will then examined under light microscope. The lesion depth will be scored on a scale from 0 to 4, where 0 = sound, 1 = enamel caries limited to the outer half of the enamel, 2 = enamel caries in the inner half of the enamel, 3 = dentinal caries in the outer half of the dentine, and 4 =dentinal caries in the inner half of the dentine
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Extracted teeth are radiographed and examined by diagnodent and then sections are examined under light microscope
| Arm | Type | Receives |
|---|---|---|
| Extracted teeth | Other | Diagnostic Test: DiagnodentExtracted teeth with intial caries without cavitation is examined by diagnodent and digital imaging and then by light microscope |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Extracted posterior teeth Visually intact occlusal surfaces or a variety of occlusal carious lesions, but no obvious cavities
- Removal of organic material and stains from the surfaces, the teeth will be immersed in 10% sodium hypochlorite solution for 20 min, followed by rinsing in distilled water for 20 min. The teeth will then stored in saturated thymol solution or formalin.
- The teeth will be arranged in pairs and mounted in plaster blocks.
Key exclusion criteria (2 listed)
- Teeth with deep cavity
- -
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 |
|---|---|---|
| Diagnodentusing DIAGNDENT depends on the principle that when 655nm wavelength of Diode laser is irradiated on dental surface, intraoral bacteria metabolites will absorb it and then metabolites emit a red fluorescence. The dental surface will reflect this fluorescence and gives number between 0 and 99 on the screen of the DIAGNdent. | Diagnostic test | Extracted teeth |
Primary outcome
To detect of occlusal caries
Time frame: 4 months
Primary Outcome Measure: 1.To detect of occlusal caries To detect occlusal caries.42 teeth with initial non cavitated caries will be examined by kavodiagondent and then radiographed. The occlusal surfaces will be carefully scanned and measured 3 times when wet, and 3 times after they had been wiped with paper tissues and exposed to air for about 2 min in room temperature.the teeth will be radiographed.The radiographs will be examined by 4 radiologists. The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth. The following scale was used: 1 = definitely not caries, 2 = probably not Caries, 3 = questionable, 4 = probably caries, and 5 = definitely caries. the light microscope will be used as gold standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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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 Diagnodent in people with Condition, 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 3 inclusion and 2 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 20 Mar 2023. 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?
To detect of occlusal caries (time frame: 4 months). 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 20 Mar 2023.