Evaluation of Caries Detection Methods

Diagnoses Disease Clinical Trial

Official title:

Clinical Performance of Diagnostic Methods in Early Occlusal Caries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064566
• Other study ID #: 2017-1-AP1-2000
• Status: Not yet recruiting
• Start date: October 20, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: September 2021
• Source: Mersin University
• Contact: Nazan Koçak Topbas, PhD
• Phone: +905458297898
• Email: nazankocak[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 101
• Est. completion date: December 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caries
• Diagnoses Disease

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mersin University	Yenisehir	Mersin

Sponsors (2)

Lead Sponsor	Collaborator
Nazan Kocak Topbas	Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

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