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

Detection of Residual Caries on Class II Cavity Walls in Primary Teeth Following Atraumatic Restorative Treatment (ART): A Comparative Evaluation of Fluorescence-Aided Caries Excavation (FACE), Caries Detection Dye, and Clinical Assessment

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Dental Caries
• Intervention / Treatment: Diagnostic test: FACE + Caries Detection Dye; Diagnostic test: FACE + Visual-Tactile Examination

Detailed Description

Effective management of dental caries in primary teeth is of great importance for pain relief, infection prevention, and the maintenance of a child's overall health. Atraumatic Restorative Treatment (ART), which is frequently preferred in pediatric patients and in regions with limited resources, is a minimally invasive approach that involves the selective removal of carious tissue using hand instruments instead of rotary tools, followed by restoration of the cavity with glass ionomer cement. This method aims to preserve tooth structure, enhance patient comfort, and reduce pulpal irritation. However, the primary limitation of ART is that caries removal relies on the clinician's visual and tactile assessment. This subjectivity increases the risk of residual caries remaining on the cavity walls, which can negatively affect the success and long-term durability of the restoration. The presence of a larger pulp chamber and thinner dentin structure in primary teeth further exacerbates this risk.

Reliable detection of residual caries is therefore crucial to the success of ART. Nevertheless, traditional methods such as clinical observation and caries detection dyes have notable limitations. Clinical observation is subject to low reproducibility due to its dependence on individual experience and judgment, while caries detection dyes can stain not only infected dentin but also demineralized yet healthy tissue, potentially leading to unnecessary tissue removal and an increased risk of pulp exposure. This outcome contradicts the minimally invasive philosophy of ART. Consequently, the use of more objective and precise techniques, such as Fluorescence-Aided Caries Excavation (FACE), has gained increasing importance for accurate detection of residual caries and improvement of treatment outcomes.

Participants in this study will consist of children aged 4 to 9 years who are medically healthy and capable of cooperating during the examination. Each primary molar will be evaluated in six distinct regions: axial wall, gingival floor, enamel-dentin junction, buccal wall, lingual wall, and pulpal wall. The assessment will be conducted sequentially using three different methods: Fluorescence-Aided Caries Excavation (FACE), caries detection dye (Caries Detector, Kuraray, Okayama, Japan), and clinical observation. The FACE method will be performed in a non-contact manner using the D-light Pro GC device (DT mode, GC Europe NV, Leuven, Belgium). The other two methods will involve visual-tactile examination under standard clinical conditions.

All evaluations will be carried out under identical conditions by two independent observers, and each cavity wall will be recorded as either "caries present" or "caries absent." The collected data will be transferred to the SPSS software for statistical analysis and coded as 1/0 (present/absent). In addition, participants' age, gender, dmft index, tooth location (maxilla/mandible), and tooth type (first or second primary molar) will be documented. These variables will allow for the statistical evaluation of potential demographic and clinical factors associated with the presence of residual caries. After the application of all three diagnostic methods on the same cavity, if any of the techniques indicated the presence of residual caries, the clinician-at their discretion-performed additional excavation to remove the affected tissue before proceeding to the final restoration. All teeth were subsequently restored using high-viscosity glass ionomer cement, in accordance with the ART protocol.

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İdil Ay Şimşek, Research Assistant; Phone Number: 00905549907321; Email: ay.idil@yahoo.com
• Study Contact Backup: Name: Burak Çarıkçıoğlu, Associate Professor; Phone Number: 00905054956091; Email: carikcioglub@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kepez
    • Çanakkale, Kepez, Turkey (Türkiye), 17100
      • Recruiting
      • Canakkale Onsekiz Mart University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FACE + Caries Detection Dye	Diagnostic test: FACE + Caries Detection Dye; Residual caries detection performed using FACE and caries detection dye.
Active Comparator: FACE + Visual-Tactile Examination	Diagnostic test: FACE + Visual-Tactile Examination; Residual caries detection performed using FACE and visual-tactile method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of residual caries detection by visual-tactile examination	Visual-tactile inspection will assess color, hardness, and texture of the dentin surface. Soft or dark dentin areas, or those producing a "catch" when probed, will be considered positive for residual caries.	Baseline (immediately after caries removal procedure; up to 5 minutes; no follow-up required)
Assessment of residual caries detection by caries detector dye	Caries detector dye (Caries Detector, Kuraray, Japan) will be applied for 10 seconds and rinsed. Areas showing red or pink staining will be classified as residual caries.	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)	Using the D-Light Pro device (GC Europe), cavity walls will be examined under violet-blue excitation light. Red-orange fluorescence areas will be identified as residual caries; green fluorescence areas will be considered sound dentin.	Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
Assessment of residual caries detection rate per cavity wall	For each cavity, residual caries presence (yes/no) will be recorded in six specific regions (axial, gingival, enamel-dentin junction, buccal, lingual, and pulpal). The percentage of positive areas will be calculated for each diagnostic method.	Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)

Collaborators and Investigators

• Sponsor: Çanakkale Onsekiz Mart University
• Investigators: Principal Investigator: Burak Çarıkçıoğlu, Associate Professor, Canakkale Onsekiz Mart University; Principal Investigator: Hilal Öztürk, Research Assistant, Canakkale Onsekiz Mart University; Principal Investigator: İDİL AY ŞİMŞEK, Research Assistant, Canakkale Onsekiz Mart University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: primary teeth; FACE; dental atraumatic restorative treatment; dentin caries; residual caries
• Other Study ID Numbers: COMU-BCARIKCIOGLU-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No