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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-9
SponsorÇanakkale Onsekiz Mart University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: FACE + Caries Detection DyeActive comparator 1 intervention
Group B: FACE + Visual-Tactile ExaminationActive comparator 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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.

Time frame
Baseline (immediately after caries removal procedure; up to 5 minutes; no follow-up required)
2

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.

Time frame
Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
3

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.

Time frame
Baseline (immediately after caries removal procedure; up to 10 minutes; no follow-up required)
4

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.

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

Other outcomes

Sponsors and contacts

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