Solvay Dental 360 a Solvay business line dedicated to innovation in dental care materials, announced today the release of new data from the pivotal REFRAME RPD Post-Market Clinical Study — one of the most extensive cohort trials conducted on removable partial dentures (RPDs) to date. The study results show that four out of five patients preferred a frame made from Ultaire AKP over those made from cobalt chrome (CoCr), while also demonstrating a statistically significant improvement in their quality of life.
“We’re very excited by the REFRAME study results,” said Shawn Shorrock, global director, Solvay Dental 360. “It validates what we’ve been hearing from both dentists and their patients – that a removable partial denture made from Ultaire AKP provides a previously unattainable level of comfort and performance when compared to metal. We now have a proven solution with critical patient benefits backed by data.”
REFRAME was a prospective, non-randomized, multicenter, cohort study that evaluated the change in patient Oral Health-Related Quality of Life (OHRQoL) from wearing a CoCr RPD to wearing an Ultaire AKP RPD. Conducted by the College of Dentistry from The University of Illinois at Chicago and the School of Dentistry at the University of Leeds, the trial enrolled 40 patients who had previously worn a CoCr RPD.
The study’s primary outcome demonstrated a statistically significant improvement in patient oral health-related quality of life when wearing an Ultaire AKP frame compared to CoCr. Patients experienced improvements in the majority of OHRQoL factors, most importantly their comfort when eating, speaking and engaging in social interaction, their self-esteem, and their satisfaction with respect to their oral health.
“Globally, the increase in life expectancy and overall increase of the aging population means more patients will require an effective solution for missing teeth. Typically, dentists prescribe cobalt chrome RPDs, but patients may complain of discomfort, sensitivities, inflammation and embarrassment,” said Professor Brian Nattress, DDS and Principal Investigator from the School of Dentistry at the University of Leeds. “The REFRAME study is important because it looked not only at dental outcomes but also the impact on patient quality of life. The results were remarkable as the totality of the data showed statistically significant improvements in oral health quality of life with Ultaire AKP compared to cobalt chrome. When given the option, 80% of patients preferred an Ultaire AKP RPD over cobalt chrome.”
Ultaire AKP is an innovative aryl ketone polymer that was purposefully engineered to provide a biocompatible, lightweight and non-irritating alternative to metal for removable partial dentures. Unlike other plastic RPD materials, which are often flimsy and can cause remaining teeth to move, Ultaire AKP was specifically designed to be rigid and supportive yet have enough flexibility to protect the abutment teeth and preserve gum tissue. Ultaire AKP frames are digitally designed for an accurate fit and hold their shape so that they require fewer adjustments, saving both dentists and patients time and money.
Ultaire AKP is available in the United States, Canada, United Kingdom, Germany, and other select member states of the European Union, with regulatory approval via 510K clearance, CMDCAS and CE mark. It is designed and manufactured in the U.S. under FDA and International Organization for Standardization (ISO) guidelines.
Source: Company Press Release
