Evaluation of Caries Detection Methods

September 21, 2021 updated by: Nazan Kocak Topbas

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Mersin
      • Yenisehir, Mersin, Turkey, 33150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study sample will be comprised of 100 third molars requiring extraction with non-cavitated but suspected occlusal caries from 101 patients.

Description

Inclusion Criteria:

  • 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,
  • 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.

Exclusion Criteria:

  • Patients younger than 18
  • Patients that can not be recruited according to the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: caries assessment
clinical visual examination (ICDAS II), digital io radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), and micro-CT images.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 1 month
The accuracy of caries detection methods will be evaluated when compared to the gold standard Micro CT.
1 month
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.
1 month
Intraclass correlation coefficient (ICC)
Time Frame: 1 month
Intra- and inter-observer reproducibility will be assessed by intraclass correlation coefficient (ICC).
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient comfort/pain analysis by using Visual Analog Scale (VAS)(comparative assessment of the tests):
Time Frame: 1 month
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.
1 month
Clinical time efficacy (comparative assessment of the tests)
Time Frame: 1 month
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)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nazan Kocak Topbas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazan Koçak Topbaş, PhD, Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-1-AP1-2000

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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