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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
FACE + Caries Detection Dye
Diagnostic testResidual caries detection performed using FACE and caries detection dye.
FACE + Visual-Tactile Examination
Diagnostic testResidual caries detection performed using FACE and visual-tactile method.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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