A new clinical trial sponsored by Çanakkale Onsekiz Mart University aims to explore the combined effect of Silver Diamine Fluoride (SDF) and LED activation on residual caries activity in Class II dental cavities. This study is currently listed as “not yet recruiting” and will leverage DIAGNOdent measurement technology to assess outcomes. Professionals in clinical research, regulatory affairs, and dental care will find this study relevant as it investigates an innovative approach to caries management.
What is the objective of this study?
The study is designed to evaluate the effects of combining Silver Diamine Fluoride (SDF) application with LED activation on the activity of residual caries in Class II dental cavities. Class II cavities often present challenges due to their location and difficulty in achieving thorough cleaning and sealing.
Researchers aim to determine whether this combined intervention improves outcomes compared to standard treatments. Measurements will be based on caries activity levels, quantified using the DIAGNOdent device, a laser fluorescence tool known for its precision in detecting active caries lesions.
What methods will be used?
This clinical trial will use the following methods:
- Application of Silver Diamine Fluoride, a topical agent known for its antibacterial properties and ability to halt caries progression.
- LED activation to potentially enhance the therapeutic effects of SDF by improving penetration and activation of the material in dental tissues.
- DIAGNOdent measurements to provide an objective and reliable evaluation of residual caries activity over time.
The study will follow strict protocols consistent with Good Clinical Practice (GCP) guidelines, ensuring data integrity and patient safety throughout the trial.
Why is this study important?
Dental caries continues to be a significant public health challenge globally, affecting millions of individuals annually. Innovations such as the combination of Silver Diamine Fluoride and LED activation could offer new, minimally invasive solutions for managing active caries, particularly in hard-to-treat areas such as Class II cavities.
If successful, this intervention could reduce the need for extensive restorative procedures, improving outcomes for both patients and dental practitioners. Beyond clinical benefits, this study could pave the way for enhanced regulatory recognition of combined therapies in dental care.
Frequently Asked Questions
1. How is this study different from other caries management research?
This trial will uniquely evaluate the impact of LED activation as an adjunct to Silver Diamine Fluoride application, combining preventive and innovative technologies in its approach.
2. What is DIAGNOdent, and how does it work?
DIAGNOdent is a laser fluorescence device used to measure caries activity non-invasively. It quantifies fluorescence emitted by bacterial by-products, providing an objective indicator of active caries.
3. What is the recruitment status of this study?
The study is currently listed as “not yet recruiting.” Further updates will be provided when recruitment begins.
Conclusion
This upcoming clinical trial represents an important step in leveraging advanced technologies for dental caries management. By combining Silver Diamine Fluoride and LED activation, the study may provide evidence-based insights with significant implications for dental care practices. Clinical, regulatory, and quality professionals should monitor updates to assess potential applications and outcomes of this innovative intervention.
Disclaimer
This article is for informational purposes only and does not constitute legal or professional advice. Readers should consult relevant regulatory guidance or professionals for specific applications.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07250009?term=medical+device