Ankara Yildirim Beyazıt University is advancing clinical insights into root canal therapy through a significant study assessing the efficacy of various irrigation solutions and activation methods. This research focuses on relieving postoperative pain and improving the quality of life for patients with irreversible acute pulpitis.
In this article:
- What are the studied methods?
- What does the study reveal?
- Impacts on patient care and regulatory considerations
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Full announcement information
What are the studied methods?
This clinical trial explores three activation methods combined with two different irrigation solutions:
- Irrigation solutions: Sodium Hypochlorite and Etidronic Acid.
- Activation methods: Conventional Syringe, EDDY (sonic activation), and Diode Laser.
Six different intervention scenarios were analyzed, aiming to uncover the optimal combination for minimizing postoperative pain. These methodologies align with regulatory standards for the evaluation of dental medical devices.
What does the study reveal?
While the study is currently marked as active but not recruiting, early indicators suggest diverse effects depending on the combination of irrigation solutions and activation methods utilized. The purpose is to inform clinicians about the comparative advantages and practical applications of each method. Results of this trial will also have implications for dental medical device manufacturers and regulatory submissions under MDR Annex XIV guidelines.
Patient feedback on postoperative pain and overall quality-of-life improvements is a critical outcome being monitored. Data from this study is expected to strengthen evidence-based strategies in endodontics.
Impacts on patient care and regulatory considerations
If the study identifies a combination that significantly reduces pain and enhances patient quality of life, it could lead to widespread adoption in clinical practice globally. Such findings would also support regulatory bodies in approving medical devices for specific intended uses. This is especially relevant under MDR requirements for performance and safety evaluations.
The study’s implications extend to medical device manufacturers seeking evidence to support clinical efficacy claims in regulatory submissions. Companies investing in sonic or laser-based activation tools may face market opportunities or adjustments based on these findings.
Frequently Asked Questions
-
What is the purpose of this study?
The study aims to evaluate the effectiveness of different irrigation solutions and techniques in reducing postoperative pain and improving patient quality of life during root canal treatments. -
Who is conducting this trial?
Ankara Yildirim Beyazıt University is the sponsor of the clinical trial. -
What methods are under investigation?
Sodium Hypochlorite and Etidronic Acid are compared using Conventional Syringe, EDDY, and Diode Laser activation techniques. -
When are results expected?
The study is active but not recruiting. Specific timelines for publication of results have not yet been disclosed.
Conclusion
This research acts as a pivotal step in understanding how irrigation solutions and activation methods impact root canal therapy safety and efficacy. It holds strong relevance for clinicians, researchers, and medical device manufacturers aiming to optimize performance and meet regulatory standards. Further updates will be awaited as the study progresses.
Disclaimer
This content is for informational purposes only and does not constitute legal or regulatory advice. Always consult official regulatory documentation and qualified professionals for guidance.
Full announcement information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07241650?term=medical+device