Nothing speaks louder than real-world clinical evidence

Professor De Santis, what are the main characteristics and scope of the 1000+ patient TiUltra™ study?

This prospective, real-world study included 1,027 patients treated with TiUltra™ surface implants. The study is being conducted across 29 centers in 13 countries, making it one of the largest and most diverse cohorts in this field. Unlike most randomized clinical trials, our study design allowed for the inclusion of patients typically seen in daily clinical practice, including those with comorbidities such as diabetes, a history of periodontitis, parafunctional tendencies, and those who underwent guided bone regeneration (GBR) procedures. The average patient age was 53.3 years, with 54.8% female and 45% male participants. Notably, 7.4% of the cohort were current smokers, and 25.4% of implant sites required GBR. This broad inclusion reflects the real-world complexity of dental implant patients and enhances the generalizability of our findings.

"Nobel Biocare implants with TiUltra™ surface are effective and safe for a wide range of patients, not just those who meet the strict criteria of randomized trials."

Prof. Daniele de Santis, Italy

What are the key findings and clinical implications of your research?

At one year, and up to three years after loading, the overall implant survival rate was 98.4%. Importantly, the outcomes were comparable across subpopulations, including those with comorbidities and those who underwent simultaneous GBR. For example, the failure rate in patients with at least one comorbidity was only slightly higher than in the general cohort (2.5% vs. 1.9%), and similar trends were observed in patients with GBR.

Soft tissue health indicators were also favorable. At the 1-year follow-up, there was no severe inflammation or excessive plaque accumulation at any implant site, regardless of patient risk profile. Bleeding scores and probing depths remained low, indicating healthy peri-implant tissues. These results suggest that TiUltra™ surfaces support robust soft tissue integration and minimize inflammatory complications.

The study’s real-world design demonstrates that Nobel Biocare implants with TiUltra™ surface are effective and safe for a wide range of patients, not just those who meet the typically strict criteria of randomized trials. This broad applicability is significant for clinicians, as it supports the use of TiUltra™ implants in routine practice, including in medically complex and challenging cases.

How do these findings influence future implant design and clinical practice?

Our results indicate that TiUltra™ surface can promote healthy peri-implant tissue, especially in the connective and epithelial areas. This likely broadens the clinical use of such implants and may guide the next generation of implant design. The high survival rates and favorable soft tissue outcomes, even in challenging cases, suggest that these surfaces offer long-term success and reliability for a diverse patient population.

Conclusion

This clinical study provides compelling real-world evidence supporting the safety and efficacy of TiUltra™ implant surface. With high survival rates, excellent soft tissue health, and applicability across a broad spectrum of patients, these findings are poised to influence both clinical practice and future implant innovation.