A new clinical study sponsored by Çanakkale Onsekiz Mart University focuses on enhancing diagnostic methods for detecting residual caries in primary teeth following Atraumatic Restorative Treatment (ART). The research could improve outcomes for pediatric dental care professionals and caregivers, especially in managing class II cavity walls.
In this article:
What changed?
The trial is set to evaluate two distinct diagnostic approaches: the FACE technique combined with caries detection dye and the FACE technique paired with visual-tactile examination. Both methods aim to accurately identify residual caries in primary teeth, a challenging aspect of ART procedures.
Primary dental caries remains a major health issue in pediatric dentistry globally. This research aims to refine detection strategies, potentially reducing missed diagnoses and complications post-treatment.
Study details
Purpose and scope
This clinical trial seeks to enhance early detection capabilities for residual caries post-ART. It compares traditional visual-tactile examination against caries detection dye, both used in conjunction with FACE technology.
The study will be conducted by Çanakkale Onsekiz Mart University and is listed on ClinicalTrials.gov under the identifier NCT07250022. Recruitment has not yet begun.
Key methodologies
- Detection techniques: FACE + Caries Detection Dye vs. FACE + Visual-Tactile Examination.
- Patient population: Pediatric patients with primary dental caries undergoing ART.
- Clinical focus: Evaluating the accuracy, safety, and efficiency of both diagnostic methods.
Results from this trial may offer regulatory bodies, clinicians, and dental technology designers actionable insights into improving pediatric dental care workflows.
Why this research matters
Residual caries pose a challenge for effective patient recovery and long-term dental health. Precise detection methods reduce the risk of retreatment while boosting patient outcomes. Regulatory professionals assessing device performance and post-market surveillance data can find this study particularly relevant.
Pediatric dental care faces unique challenges given the age group and the behavioral needs of young patients. ART techniques aim to be minimally invasive, but secondary prevention through reliable detection methods is critical.
FAQs
1. Who is the sponsor of this study?
Çanakkale Onsekiz Mart University is the principal sponsor of the research.
2. What diagnostic methods are being tested?
FACE combined with caries detection dye and FACE combined with visual-tactile examination are being evaluated.
3. When does recruitment begin?
The study is marked as “not yet recruiting” according to ClinicalTrials.gov.
4. Why focus on primary teeth?
Primary teeth are essential for oral development, and ensuring proper treatment can help prevent long-term dental issues.
Conclusion
This study has the potential to address key challenges in pediatric dentistry by refining diagnostic methods for detecting residual caries. Innovations in detection tools can aid dental professionals in delivering safer and more effective care. Regulatory teams monitoring advancements in diagnostic devices should follow developments related to this study carefully.
Disclaimer
This article provides general information based on the clinical trial listed on ClinicalTrials.gov. It is not regulatory or legal advice. Always consult professional guidance for compliance questions or decisions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250022?term=medical+device