On September 29, 2025, a new clinical trial announced by Menoufia University and Mansoura University aims to explore the differences in crestal bone loss between subcrestal implants using narrow tie-base abutments and regular tie-base abutments. This study targets professionals involved in clinical practice, quality assurance, and regulatory affairs for medical devices. The trial’s outcomes could have implications for implant design and long-term performance.
Study Details
The upcoming clinical trial, officially listed on ClinicalTrials.gov under the identifier NCT07196228, focuses on the outcomes of subcrestal implants with two different tie-base designs: narrow and regular abutments. Sponsored by Menoufia University and Mansoura University, this research aims to analyze the effects of these designs on crestal bone response—a critical factor in implant success and longevity.
The study remains in the preparatory phase and is not yet recruiting participants. The researchers will use intervention devices specifically designed for this trial, differentiating between the narrow tie-base abutment in Arm 1 and the regular tie-base abutment in Arm 2.
Clinical Focus and Goals
What Changed?
This investigation brings renewed attention to crestal bone loss, a common condition impacting the success rates of dental implants. By homing in on tie-base abutment design variations, researchers aim to clarify their role in mitigating or exacerbating bone loss.
The trial’s design involves close monitoring of patients who receive subcrestal implants featuring these tie-base options. Crestal bone measurements will be recorded systematically to determine whether one design promotes better performance under clinical conditions.
Who Is Affected?
Dental health professionals, implant manufacturers, and regulatory teams involved in medical device evaluation may find this study impactful. Evidence-based insights could guide both product innovation and compliance practices in the sector.
Implications for Regulatory and Clinical Practice
Why Is This Study Important?
The results may influence medical device safety guidelines and implant design protocols, aligning them more closely with MDR Annex XIV requirements for ongoing performance monitoring. Narrow tie-base abutments, if demonstrated to reduce crestal bone loss, could set new benchmarks for implant technologies.
Regulatory Context
Professionals should note that interventions involving structural alterations to implants are subject to rigorous evaluation under MDR regulations in Europe and FDA guidelines in the US. Results from this trial could provide sufficient evidence to inform labeling changes or clinical recommendations.
FAQ
1. What is crestal bone loss?
Crestal bone loss refers to the deterioration of the bone near the top of the implant, often leading to implant instability or failure.
2. What are tie-base abutments?
Tie-base abutments are structural components connecting the implant to the prosthetic tooth. Their design can impact bone integration and stability.
3. How can I participate in the trial?
The study is currently in the preparatory phase and not yet recruiting. Interested parties should monitor ClinicalTrials.gov for updates.
Conclusion
The upcoming trial serves as a promising step forward in understanding implant designs and their impacts on crestal bone health. Results could shape future clinical practices, product development, and regulatory standards for tie-base designs. Dental professionals and manufacturers should keep a close eye on this study for actionable insights.
Disclaimer
This article provides general information for professionals and does not constitute legal or regulatory advice. Always consult applicable MDR or FDA guidelines for compliance purposes.
Link to Full Study Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07196228?term=medical+device