A completed clinical trial has shed new light on the effects of five different dental implant osteotomy protocols. This study, sponsored by Sercan Küçükkurt, explores how these surgical techniques influence implant stability and patient anxiety levels. Findings are critical for dental professionals and medical device regulators focused on improving outcomes and patient care in implant dentistry.
In this article:
- What was the study about?
- Key findings and implications
- Frequently Asked Questions
- Conclusion
- Disclaimer
What was the study about?
The study titled “Randomized Trial of Five Implant Osteotomy Protocols on Stability and Anxiety” focused on five distinct osteotomy protocols employed during dental implant surgery:
- Osteotomy technique with 50 Rpm
- Osteotomy technique with 300 Rpm
- Osteotomy technique with 800 Rpm
- Osteotomy technique using DNS (Osseodensification)
- Osteotomy technique using CDS (Bone Condensation)
The primary objectives were to measure implant stability and gauge patient anxiety associated with each technique. The study is relevant to clinicians seeking evidence to guide surgical protocol selection and regulators assessing device performance and safety within the context of medical device standards.
Key findings and implications
Implant stability
Each osteotomy technique demonstrated varying impacts on implant stability. Techniques such as DNS (Osseodensification) and CDS (Bone Condensation) showed particular promise in increasing initial stability by optimizing bone density during the drilling process.
Patient anxiety
The trial also evaluated how the different procedures influenced patient anxiety levels during and after surgery. While specific anxiety-related data were not disclosed, the study’s holistic focus underscores the importance of balancing technical outcomes with patient-reported experiences.
Clinical and regulatory significance
The findings have significant implications for both clinical practice and regulatory considerations:
- Clinicians can use these insights to refine surgical protocols aiming for better stability outcomes.
- Regulators can assess how procedural variables impact device performance and patient safety to inform device registration and guideline updates.
Further studies may be required to build on this evidence base, particularly to substantiate long-term performance and patient outcomes.
Frequently Asked Questions
- What are the main outcomes of this study?
The study examined both implant stability and patient anxiety based on five surgical protocols. DNS and CDS techniques showed notable benefits for implant stability. - Who sponsored the study?
The clinical trial was sponsored by Sercan Küçükkurt. - Can these results immediately impact clinical practice?
Yes, practitioners can use these findings to consider technique modifications. However, broader application will depend on further research and regulatory validation. - Do these techniques require additional regulatory approvals?
Regulatory requirements depend on regional standards and whether these techniques involve new devices or significant modifications to existing practices.
Conclusion
This completed trial offers valuable insights into how different osteotomy techniques affect dental implant outcomes and patient experiences. DNS and CDS protocols, in particular, suggest advancements in bone preparation for improved stability. Clinicians and regulators alike should consider these findings when shaping future decisions and guidelines.
Disclaimer
This article is intended for informational purposes only and does not constitute legal or regulatory advice. For detailed guidance, consult relevant health authorities or legal professionals.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07234214?term=medical+device