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NCT Number: NCT07250022

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

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FACE + Caries Detection Dye

Diagnostic Test

Residual caries detection performed using FACE and caries detection dye.

FACE + Visual-Tactile Examination

Diagnostic Test

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

Primary outcomes

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

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

    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).

Secondary outcomes

  1. Assessment of residual caries detection by visual-tactile examination

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

    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.

  2. Assessment of residual caries detection by caries detector dye

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

    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.

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

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

    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.

  4. Assessment of residual caries detection rate per cavity wall

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Burak Çarıkçıoğlu, Associate Professor

CONTACT

[email protected]

00905054956091

İdil Ay Şimşek, Research Assistant

CONTACT

[email protected]

00905549907321

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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