An important step in dental health technology has been achieved with the completion of a clinical trial evaluating tooth mobility using the Osstell device. Sponsored by Mustafa Kemal University, this study aimed to explore effective methods for measuring tooth mobility—a condition often linked to periodontal diseases and trauma.
Published on October 5, 2025, this news is relevant for clinical, quality, and regulatory teams seeking evidence-based insights into medical device advancements.
In this article
- What changed?
- Study findings
- How does the Osstell device measure tooth mobility?
- FAQ
- Conclusion
- Disclaimer
- Full announcement
What changed?
The study introduced innovative methodologies for assessing tooth mobility using medical devices, emphasizing the Osstell unit. Results indicated the device offers precise measurements supplementing traditional Miller mobility assessments. ClinicalTrials.gov lists the trial as completed.
For regulatory teams, this completion signals potential advancements in product validations and performance benchmarking tools for periodontal health devices.
Study findings
Tooth mobility often results from periodontal instability or external trauma, impacting oral health. Accurate measurement of mobility ensures proper diagnosis and treatment planning. This trial tested the Osstell device against the established Miller scoring system, ensuring regulatory-compliant comparisons.
Findings suggest the Osstell device can provide quantitative data on tooth stability, which traditional scoring methods may lack. Such structured readings could support better engineering of treatment interventions and strengthen clinical evidence for device clearances.
How does the Osstell device measure tooth mobility?
The Osstell system relies on resonance frequency analysis (RFA). Unlike subjective tools such as Miller’s index, RFA produces objective metrics on implant micromotion and stability—even valuable in managing loosening or instability of natural teeth.
For manufacturers, this technology could inform validation strategies under global regulatory frameworks, including EU MDR Annex XIV and FDA requirements.
FAQ
1. What is the Osstell device used for?
The Osstell unit measures implant stability and mobility using resonance frequency analysis. It’s increasingly tested for natural teeth clinical applications.
2. Why is assessing tooth mobility important?
Tooth mobility evaluation directly supports periodontal disease diagnostics and customized treatment planning.
3. How does this impact regulatory processes?
Innovative tools such as Osstell devices may aid manufacturers in meeting performance testing and validation requirements under MDR or FDA standards.
Conclusion
This study highlights actionable advancements in assessing tooth mobility. Dental professionals and product developers can now explore Osstell data for precision-driven patient outcomes, while regulators might see new device clearance propositions informed by trial results.
Disclaimer
This article is for informational purposes only and does not constitute legal or regulatory advice.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188168?term=medical+device