Hallym University Sacred Heart Hospital Achieves World’s First Clinical Trial Success for Next-Generation Titanium Alloy Implant

Titanium Alloy with Bone-Like Elasticity and High Strength
100% Success and Survival Rate Confirmed Over 12 Months

A team of Korean researchers has successfully conducted the world’s first clinical trial of a next-generation implant alloy in human subjects.

On April 16, Hallym University Sacred Heart Hospital announced that the research team of Professors Yang Byeongeun, Byun Soohwan, and Park Sangyun from the Department of Dentistry and Oral and Maxillofacial Surgery succeeded in a clinical trial applying a next-generation implant alloy—stronger than conventional titanium and with physical properties more similar to bone—to human subjects. The research results were published in the international journal 'Journal of Functional Biomaterials.'

From the left, Yang Byung-eun, Byun Soo-hwan, and Park Sang-yoon, professors at the Department of Oral and Maxillofacial Surgery, Hallym University Sacred Heart Hospital. Hallym University Sacred Heart Hospital

Currently, the most widely used metal for implant materials is pure titanium. While it is highly compatible with the human body, its strength and durability are not entirely sufficient. When the implant diameter is thin or biting forces are strong, there is a risk of fracture with long-term use.

Another problem is the phenomenon known as "stress shielding." Stress shielding occurs when titanium implants, which are much harder than human bone, absorb most of the biting force, preventing the surrounding bone from receiving adequate stimulation, which gradually weakens or resorbs the bone.

To address these limitations, the research team developed a new beta-type titanium alloy (Ti-Nb-Zr, hereafter TNZ) implant by adding niobium (Nb) and zirconium (Zr), and evaluated both its material properties and clinical performance. The TNZ alloy used in this study was produced by mixing approximately 40% niobium and 7% zirconium into titanium.

The research was conducted in two stages. First, analysis with a scanning electron microscope (SEM) and energy-dispersive spectrometer (EDS) confirmed that the alloy components were uniformly distributed across the surface of the implant. Next, strength measurements showed that the tensile strength of the TNZ alloy averaged 1,139 MPa, about 27% higher than that of conventional implant materials. Meanwhile, the elastic modulus, which indicates the elasticity of the metal, was 75 GPa—lower than that of standard titanium—making it closer to the actual properties of human bone.

The ability to withstand repeated biting forces was also significantly improved. In fatigue life tests, TNZ implants withstood an average of approximately 1.06 million cycles of repeated loading, enduring about four times longer than conventional titanium implants.

The research team then conducted a clinical trial with 80 adult patients at Hallym University Sacred Heart Hospital and Seoul National University Bundang Hospital. Patients were randomly assigned to receive either a TNZ implant or a conventional titanium implant. Their progress was monitored for six and twelve months following the procedure.

The results showed that both groups achieved a 100% success rate and survival rate for the implants. There were no significant differences between the two groups regarding gum health or the stability of the bone around the implant. Furthermore, analysis of microstructural changes in the bone around the implant using radiographic images revealed that the bone remained stable and within the normal range in all patients. Notably, no adverse events or abnormal reactions were reported, confirming the safety and biocompatibility of the TNZ alloy implants.

Professor Yang stated, “This study is meaningful as it is the world’s first research to apply a new titanium alloy to dental implants and conduct a clinical trial in humans. We have confirmed the potential of this next-generation implant material, which is stronger than conventional titanium while possessing physical properties similar to bone.”

He added, “Especially for patients with strong biting forces, such as those who grind their teeth, or in cases where the jawbone is narrow and a thin implant must be used, this could become a new treatment option in challenging clinical situations. Moving forward, we plan to further validate the clinical advantages of the TNZ alloy implant through long-term follow-up studies and multi-center clinical trials.”

This content was produced with the assistance of AI translation services.