Evaluation of Caries Detection Methods

NCT05064566 | Unknown

• 1 other identifier: 2017-1-AP1-2000
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Caries; Diagnoses Disease

Keywords

Caries detection;; laser fluorescence; micro-CT; visual analog scale

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Patient comfort/pain analysis by using Visual Analog Scale (VAS)(comparative assessment of the tests):

  1 month

• Clinical time efficacy (comparative assessment of the tests)

  1 month

Study Arms (1)

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

Interventions

caries assessment DEVICE

clinical visual examination (ICDAS II), digital io radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), and micro-CT images.

caries diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients younger than 18

Sponsors & Collaborators

• Nazan Kocak Topbas: lead
• Mersin University: collaborator

Study Sites (1)

Mersin University

Yenişehir, Mersin, 33150, Turkey (Türkiye)

Location

Study Officials

• Nazan Koçak Topbaş, PhD

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazan Koçak Topbaş, PhD

CONTACT

+905458297898; nazankocak@mersin.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: October 1, 2021
• Study Start: October 20, 2021
• Primary Completion: October 20, 2022
• Study Completion: December 20, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

TU (1)