CariesNCT05064566
Evaluation of Caries Detection Methods
An observational study of Caries and Diagnoses Disease, run by Nazan Kocak Topbas at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caries, Diagnoses Disease
- What is being tested?
- caries assessment
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2021to 20 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study sample will be comprised of 100 third molars requiring extraction with non-cavitated but suspected occlusal caries from 101 patients.
Who may be able to join
- According to the American Society of Anesthesiologists (ASA) only status 1/ healthy patients
- Completely erupted permanent dentition,
- No fixed orthodontic apparatus, prosthetic restoration and filling material,
- A minimum age of 18 years,
- At least one third erupted molar teeth (third mandibular or third maxillary molar from each patient was included),
- Non cavitated occlusal caries,
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- Teeth with no hypoplasia or hypomineralization,
- Third molar teeth that require extraction for surgery, orthodontics and prosthetic reasons,
- If clinical indicators suggest a current caries risk or activity that required additional diagnosis, the patients will be asked to participate in this additional examination.
Who cannot join
- Patients younger than 18
- Patients that can not be recruited according to the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University
Yenişehir, Mersin, 33150
Nazan Kocak Topbas, PhD, 905458297898, nazankocak@mersin.edu.tr
About this study
Official title: Clinical Performance of Diagnostic Methods in Early Occlusal Caries
The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.
Read the detailed description
Studies regarding comparison of diagnostic techniques for caries detection are generally conducted under in vitro conditions due to ethical concerns. Considering the many recently published in vitro studies which attempted to assess the diagnostic ability of different caries diagnosis systems, it is not possible to know at what rate in vitro findings are applicable to the clinical situation.The investigators would like to assess initial occlusal caries lesions by using different diagnostic methods under in vivo conditions. In the present study, the investigators will assess diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. The null hypothesis of the study is that no significant difference exists for the clinical performance of the evaluated methods in detecting non-cavitated occlusal caries in either the enamel or the dentin. This prospective study will include 101 third molars of 101 patients with non-cavitated occlusal caries requiring extraction. ICDAS II, BW, NIR-LT and LF examinations will be carried out by two examiners. Gold standard will be determined by micro-CT imaging after extraction. Intraclass correlation coefficient (ICC) value will be calculated for examiner agreement. Accuracy rate, sensitivity, specificity, predictive values and areas under receiver operating characteristic curves (Az) will be calculated. Clinical application time and patient comfort/pain analysis will be compared. Nonparametric variables will be assessed by Kruskal Wallis Test. Significance level will be set at p<0.05.
- Conditions
- Caries, Diagnoses Disease
- Being tested
- caries assessment
- Keywords
- Caries detection;, laser fluorescence, micro-CT, visual analog scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caries assessmentDevice
clinical visual examination (ICDAS II), digital io radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), and micro-CT images.
| Study group | Role | What they receive |
|---|---|---|
| caries diagnosis | diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. Receives: Device: caries assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The accuracy of caries detection methods will be evaluated when compared to the gold standard Micro CT.
Measured: 1 month
Receptor operating characteristic (ROC) curves
Receptor operating characteristic (ROC) curves (Az) will be calculated to show the caries distinguishing ability of each caries detection method and the observer.
Measured: 1 month
Intraclass correlation coefficient (ICC)
Intra- and inter-observer reproducibility will be assessed by intraclass correlation coefficient (ICC).
Measured: 1 month
Secondary outcomes (2)
Patient comfort/pain analysis by using Visual Analog Scale (VAS)(comparative assessment of the tests):
The patients will be asked to rate their feelings (based on comfort and pain) from absence of discomfort and pain to extreme discomfort and pain (between 0 and 10) for each clinical method.
Measured: 1 month
Clinical time efficacy (comparative assessment of the tests)
Clinical application times from the beginning of the procedure to the end of the procedure for each method will be calculated by using a stopwatch. (example: LF pen 10 sn)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion20 Oct 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazan Kocak Topbas
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Sponsor-investigator, Nazan Kocak Topbas, Mersin University
- Investigators
- Nazan Koçak Topbaş, PhD, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064566
- Sponsor's protocol ID
- 2017-1-AP1-2000
- Status last verified
- Sep 2021
- First submitted
- 28 May 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Diagnostic Methods in Early Occlusal Caries
- ClinicalTrials.gov ID
- NCT05064566
- Acronym / sponsor ID
- 2017-1-AP1-2000
- Conditions
- Caries, Diagnoses Disease
- Keywords
- Caries detection;, laser fluorescence, micro-CT, visual analog scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Nazan Kocak TopbasUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 20 Oct 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 1 Oct 2021 (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 investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.
Detailed description
Studies regarding comparison of diagnostic techniques for caries detection are generally conducted under in vitro conditions due to ethical concerns. Considering the many recently published in vitro studies which attempted to assess the diagnostic ability of different caries diagnosis systems, it is not possible to know at what rate in vitro findings are applicable to the clinical situation.The investigators would like to assess initial occlusal caries lesions by using different diagnostic methods under in vivo conditions. In the present study, the investigators will assess diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. The null hypothesis of the study is that no significant difference exists for the clinical performance of the evaluated methods in detecting non-cavitated occlusal caries in either the enamel or the dentin. This prospective study will include 101 third molars of 101 patients with non-cavitated occlusal caries requiring extraction. ICDAS II, BW, NIR-LT and LF examinations will be carried out by two examiners. Gold standard will be determined by micro-CT imaging after extraction. Intraclass correlation coefficient (ICC) value will be calculated for examiner agreement. Accuracy rate, sensitivity, specificity, predictive values and areas under receiver operating characteristic curves (Az) will be calculated. Clinical application time and patient comfort/pain analysis will be compared. Nonparametric variables will be assessed by Kruskal Wallis Test. Significance level will be set at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caries diagnosis | – | Device: caries assessmentdiagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will be comprised of 100 third molars requiring extraction with non-cavitated but suspected occlusal caries from 101 patients.
Key inclusion criteria (9 listed)
- According to the American Society of Anesthesiologists (ASA) only status 1/ healthy patients
- Completely erupted permanent dentition,
- No fixed orthodontic apparatus, prosthetic restoration and filling material,
- A minimum age of 18 years,
- At least one third erupted molar teeth (third mandibular or third maxillary molar from each patient was included),
Key exclusion criteria (2 listed)
- Patients younger than 18
- Patients that can not be recruited according to the inclusion criteria.
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 |
|---|---|---|
| caries assessmentclinical visual examination (ICDAS II), digital io radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), and micro-CT images. | Device | caries diagnosis |
Primary outcome
Accuracy
Time frame: 1 month
The accuracy of caries detection methods will be evaluated when compared to the gold standard Micro CT.
Receptor operating characteristic (ROC) curves
Time frame: 1 month
Receptor operating characteristic (ROC) curves (Az) will be calculated to show the caries distinguishing ability of each caries detection method and the observer.
Intraclass correlation coefficient (ICC)
Time frame: 1 month
Intra- and inter-observer reproducibility will be assessed by intraclass correlation coefficient (ICC).
2 secondary outcomes
Patient comfort/pain analysis by using Visual Analog Scale (VAS)(comparative assessment of the tests):
Time frame: 1 month
Clinical time efficacy (comparative assessment of the tests)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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.
Nazan Koçak Topbaş, PhD principal investigator
Mersin University
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 Caries and Diagnoses Disease, run by Nazan Kocak Topbas at 1 site in Turkey (Türkiye).
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 9 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 1 Oct 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 Turkey (Türkiye). 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?
Contact Nazan Koçak Topbaş, PhD (+905458297898, nazankocak@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 1 month). The study lists 3 primary outcomes in all. 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 1 Oct 2021.