A groundbreaking clinical trial is set to explore how computer-controlled injection systems compare to conventional syringes in reducing dental pain and anxiety in children. Sponsored by Future University in Egypt, this study aims to assess behavioral responses to two distinct dental anesthesia methods. Stakeholders in clinical research, medical device regulation, and pediatric dentistry may find these developments highly relevant.
In this article:
- Why is this study important?
- What does the study focus on?
- What do we know about the devices?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement Details
Why is this study important?
Dental pain and anxiety are significant concerns in pediatric care, often leading to distress and complications during treatment. The trial investigates whether advancements in medical devices and anesthesia delivery systems—specifically the Star Pen® computer-controlled system—can mitigate these challenges compared to traditional methods using anesthetic syringes.
The study is timely as it reflects growing interest in minimizing patient discomfort while improving clinical outcomes in dentistry. It also aligns with regulatory efforts to evaluate the safety and performance of novel medical devices.
What does the study focus on?
This trial will measure three specific factors:
- Pain Levels: Quantifying how each method impacts physical discomfort during injection.
- Anxiety Responses: Assessing emotional stress using validated scales.
- Behavioral Outcomes: Studying how pain and anxiety influence child behavior in dental settings.
Such comprehensive metrics can provide actionable insights for both manufacturers and regulatory bodies.
What do we know about the devices?
Computer-Controlled System: Star Pen®
The Star Pen® system automates the injection process to deliver anesthesia at a controlled rate. It claims to improve precision and reduce discomfort.
Conventional Syringe
Traditional anesthetic syringes remain widely used but may result in more variable injection speeds and associated discomfort.
The trial aims to ascertain whether the automation and precision of a computer-controlled device significantly outperform the manual techniques in pediatric care.
Frequently Asked Questions
1. Who is conducting the study?
The study is sponsored by Future University in Egypt.
2. What phase is the trial in?
The trial is listed as “Not yet recruiting” as of October 2025.
3. How can computer-controlled systems improve outcomes?
By delivering anesthesia at an optimal rate, they are designed to reduce injection pain and improve patient comfort.
4. Is this study focused only on children?
Yes, the primary population studied consists of pediatric dental patients.
Conclusion
With future innovations shaping medical device development, this trial offers promising insights into addressing common pain and anxiety concerns in pediatric dentistry. Regulatory professionals and device developers should monitor its outcomes for potential implications in product design and validation processes.
Disclaimer
The content provided is for informational purposes only and does not constitute legal advice. Always consult regulatory specialists for compliance matters.
Announcement Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07193342?term=medical+device