Evaluation of Caries Detection Methods

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: Not yet recruiting
• Conditions: Diagnoses Disease; Caries
• Intervention / Treatment: Device: caries assessment

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: Observational
• Enrollment (Anticipated): 101

Contacts and Locations

• Study Contact: Name: Nazan Koçak Topbaş, PhD; Phone Number: +905458297898; Email: nazankocak@mersin.edu.tr

Study Locations

• Turkey
  • Mersin
    • Yenisehir, Mersin, Turkey, 33150
      • Mersin University
      • Contact: Nazan Kocak Topbas, PhD; Phone Number: 905458297898; Email: nazankocak@mersin.edu.tr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Accuracy	The accuracy of caries detection methods will be evaluated when compared to the gold standard Micro CT.	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.	1 month
Intraclass correlation coefficient (ICC)	Intra- and inter-observer reproducibility will be assessed by intraclass correlation coefficient (ICC).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	1 month

Collaborators and Investigators

• Sponsor: Nazan Kocak Topbas
• Collaborators: Mersin University
• Investigators: Principal Investigator: Nazan Koçak Topbaş, PhD, Mersin University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 20, 2021
• Primary Completion (ANTICIPATED): October 20, 2022
• Study Completion (ANTICIPATED): December 20, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (ACTUAL): October 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: visual analog scale; laser fluorescence; micro-CT; Caries detection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID 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