New insights emerge for orthodontic professionals as a clinical trial sheds light on the effectiveness of gold-coated fixed retainer wires versus conventional stainless steel options. Sponsored by Noor Sattar Raheem, this study specifically focuses on Orthodontic Retention Appliances and measures performance in preventing orthodontic relapse.
What is the focus of the study?
The clinical trial, actively recruiting as of December 13, 2025, evaluates two orthodontic devices used in post-treatment retention. Gold-coated fixed retainer wires are compared with stainless steel fixed retainer wires in preventing orthodontic relapse. Both devices aim to maintain alignment and prevent teeth from moving out of their corrected positions.
The study highlights critical variables, including material composition, long-term retention effectiveness, and safety performance of these appliances.
How do gold and stainless steel retainers compare?
Orthodontic relapse is a challenge in post-treatment care. Gold-coated fixed retainers bring unique material advantages, such as enhanced corrosion resistance and potential biocompatibility benefits. Stainless steel retainers, widely adopted in clinical settings, are cost-effective and offer robust mechanical stability.
Gold retainers may provide better patient tolerance due to reduced allergic reactions, according to preliminary industry reports. However, stainless steel remains the standard in affordability and accessibility across various patient demographics.
The trial is designed to assess these factors and verify performance claims in evidence-based settings. Results are anticipated to clarify whether gold coatings can provide a meaningful improvement in retention outcomes compared to stainless steel.
What are the clinical implications?
This study could impact orthodontic retention protocols worldwide. If gold-coated retainers demonstrate superior performance and safety, regulatory bodies might consider material advancements in device standards for long-term use.
For manufacturers, proven effectiveness of gold-coated retainers could lead to innovation in orthodontic design and supply. Clinical teams must watch closely as findings could shift the landscape of retention practices.
This trial aligns with MDR Annex XIV principles, emphasizing device efficacy and patient safety. Orthodontic professionals and regulators should prepare to adapt practices as evidence unfolds.
Frequently Asked Questions
- Why choose gold-coated retainers over stainless steel?
Gold-coated retainers may offer better corrosion resistance and potentially reduce allergic responses in patients. - Are stainless steel retainers less effective?
No, stainless steel remain a reliable choice with proven mechanical stability, though gold’s performance is under active evaluation. - Who can participate in the study?
The trial is currently recruiting eligible participants. Contact the sponsor, Noor Sattar Raheem, for further details.
Conclusion
The ongoing study of gold-coated retainers versus stainless steel opens exciting possibilities for orthodontic care. Stakeholders should consider potential advancements in retention protocols dependent on study outcomes. Evidence-based decisions will refine best practices and enhance patient experiences globally.
Disclaimer
The information provided above is intended for regulatory and clinical professionals and does not constitute legal advice. Always consult official documentation and professional guidance when evaluating orthodontic devices.
Study Registration and Details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07280455?term=medical+device