Solvay Dental 360® Announces Results of REFRAME RPD Post-Market Clinical Study
4 out of 5 patients prefer removable partial denture frames made from Ultaire® AKP over metal
ALPHARETTA, Georgia, March 12, 2020 /PRNewswire/ -- 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.1
"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 chrome. We now have a proven solution with critical patient benefits backed by data."
REFRAME was a prospective, non-randomized, multicentre, 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.1
"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.
For more information about the REFRAME RPD Study Results, visit www.solvaydental360.com.
About Solvay Dental 360®
Solvay Dental 360® is built on Solvay's world-leading high-performance polymer portfolio, including 35 brands with over 1,500 formulations. Solvay Dental 360® is committed to revolutionizing dentistry with Ultaire® AKP, an innovative high-performance polymer for RPDs. We support dental labs and dentists with technical training and marketing. For more information, visit www.solvaydental360.com or connect on LinkedIn, Twitter, Facebook and INSTAGRAM.
Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end-markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its lightweighting materials promote cleaner mobility, its formulations optimize the use of resources, and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 24,500 employees in 61 countries. Net sales were €10.3 billion in 2018, with 90% from activities where Solvay ranks among the world's top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris Bloomberg: SOLB.BB - Reuters: SOLB.BR), and in the United States its shares (SOLVY) are traded through a level-1 ADR program. (Figures take into account the planned divestment of Polyamides).
* P-value associated with change in OHIP Score: P = 0.0005
1. Solvay Dental 360®. (2020). REFRAME RPD Post-Market Clinical Study (clinicaltrials.gov IdentifierNCT03198520).
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