Detecting leftover decay on Class II cavity walls in primary teeth after atraumatic restorative treatment
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
This tests whether a fluorescence device (FACE), a staining dye, or visual-tactile checks best find leftover decay on cavity walls in children aged 4–9 after atraumatic restorative treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | All |
| Sponsor | Çanakkale Onsekiz Mart University Academic / other |
| Locations | 1 site (Çanakkale, Kepez) |
| Trial ID | NCT07250022 on ClinicalTrials.gov |
What this trial studies
After ART is performed on asymptomatic multi-surface carious lesions in primary teeth of cooperative children aged 4–9, clinicians will use three methods—FACE, caries detection dye, and visual-tactile examination—to detect residual caries on Class II cavity walls. The study compares diagnostic agreement and effectiveness of these approaches to determine which method most reliably identifies remaining infected dentin while minimizing removal of healthy tissue. Outcomes include concordance between methods and the frequency of detected residual caries, with all procedures performed at a single university dental clinic. Findings are intended to inform clinical choices for confirming complete caries removal during ART.
Who should consider this trial
Good fit: Healthy, cooperative children aged 4–9 with asymptomatic multi-surface carious cavities in primary teeth whose parent/guardian provides written consent and who give assent are ideal candidates.
Not a fit: Children with acute dental infection, systemic health conditions, inability to cooperate, or those without suitable multi-surface carious lesions are unlikely to be eligible or to benefit from the methods tested.
Why it matters
Potential benefit: If successful, this could help dentists more accurately detect and remove leftover decay during ART, reducing repeat treatments and preserving healthy tooth structure in children.
How similar studies have performed: Previous work shows FACE has promise for improving visual detection of caries while caries detection dyes often over-stain demineralized but noninfected dentin, so evidence is mixed but FACE is encouraging.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Çanakkale, Kepez
- Canakkale Onsekiz Mart University — Çanakkale, Kepez, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Burak Çarıkçıoğlu, Associate Professor — Çanakkale Onsekiz Mart University
- Study coordinator: Burak Çarıkçıoğlu, Associate Professor
- Email: carikcioglub@gmail.com
- Phone: 00905054956091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.