Detection of Residual Caries on Class II Cavity Walls in Primary Teeth Following Atraumatic Restorative Treatment (ART)

NCT07250022 | Recruiting

• 1 other identifier: COMU-BCARIKCIOGLU-2025
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to compare the diagnostic agreement and effectiveness of three different methods-Fluorescence-Aided Caries Excavation (FACE), caries detection dye, and clinical observation-in detecting residual caries remaining on cavity walls of primary teeth following Atraumatic Restorative Treatment (ART). Through this comparison, the study seeks to identify the method that provides more reliable and accurate results, thereby contributing to clinical practice by guiding clinicians and supporting the development of strategies to enhance the long-term success of ART.

Conditions

Primary Dental Caries

Keywords

dentin caries; dental atraumatic restorative treatment; primary teeth; FACE; residual caries

Outcome Measures

Primary Outcomes (1)

• Assessment of residual caries detection accuracy using FACE and caries detector dye versus FACE and visual-tactile examination

  Residual caries detection will be performed in two diagnostic arms: (1) FACE combined with caries detector dye and (2) FACE combined with visual-tactile examination. After atraumatic caries removal, the presence or absence of residual caries will be evaluated on six cavity walls (axial, gingival, enamel-dentin junction, buccal, lingual, and pulpal). Diagnostic accuracy will be expressed as sensitivity, specificity, and overall accuracy compared with a reference standard (soft dentin confirmed by tactile evaluation).

  Baseline (immediately after caries removal procedure; single visit; up to 10 minutes; no follow-up required)

Secondary Outcomes (4)

• Assessment of residual caries detection by visual-tactile examination

  Baseline (immediately after caries removal procedure; up to 5 minutes; no follow-up required)

• Assessment of residual caries detection by caries detector dye

  Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)

• Assessment of residual caries detection by FACE (Fluorescence-Aided Caries Excavation)

  Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)

• Assessment of residual caries detection rate per cavity wall

  Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)

Study Arms (2)

FACE + Caries Detection Dye

ACTIVE COMPARATOR

Diagnostic Test: FACE + Caries Detection Dye

FACE + Visual-Tactile Examination

ACTIVE COMPARATOR

Diagnostic Test: FACE + Visual-Tactile Examination

Interventions

FACE + Visual-Tactile Examination DIAGNOSTIC_TEST

Residual caries detection performed using FACE and visual-tactile method.

FACE + Visual-Tactile Examination

FACE + Caries Detection Dye DIAGNOSTIC_TEST

Residual caries detection performed using FACE and caries detection dye.

FACE + Caries Detection Dye

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-9 years at enrollment
• Healthy children who can cooperate with dental examination
• Multi-surface carious cavities that are asymptomatic (no acute symptoms)
• Written informed consent from parent/guardian and assent from the child

You may not qualify if:

• Acute dental infection present
• Any systemic disease/condition
• Lack of cooperation during the procedure
• Refusal to participate / informed consent not obtained from parent/guardian and/or assent not obtained from the child

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

RECRUITING

Study Officials

• Burak Çarıkçıoğlu, Associate Professor

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• Hilal Öztürk, Research Assistant

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

• İDİL AY ŞİMŞEK, Research Assistant

  Çanakkale Onsekiz Mart University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak Çarıkçıoğlu, Associate Professor

CONTACT

00905054956091; carikcioglub@gmail.com

İdil Ay Şimşek, Research Assistant

CONTACT

00905549907321; ay.idil@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

TU (1)