LOWELL, Mass.–( BUSINESS WIRE )–RevBio, Inc. announced that it has received regulatory and ethics committee approval from multiple European countries to conduct a pivotal clinical trial of its dental implant stabilization product. Successful completion of this pivotal clinical trial will result in CE Mark approval for the product, allowing the company to begin commercial sales in Europe. As of the date of this press release, the company has enrolled 30 patients in this clinical trial, with an expected enrollment of 75 patients.
“The results of this ongoing international, multicenter study have exceeded expectations and demonstrated extraordinary outcomes. We are confident and extremely excited about the future,” said Patrick Schmidlin, DDS, Chair of the Department of Periodontology at the University of Zurich and one of RevBio’s pivotal clinical trial investigators. “This breakthrough material has the potential to open a new chapter in dental care and redefine what is possible in regenerative dentistry.”
RevBio has received regulatory and ethics committee approval to conduct the study at five clinical sites, including one in Switzerland, two in Belgium, one in Spain, and one in the United Kingdom. Each site is expected to enroll 12-25 patients, for a total of approximately 75 patients. The researchers approved to recruit patients in this clinical trial are Prof. Dr. med.
Patrick Schmidlin, DDS, Head of the Department of Periodontology, University of Zurich, Ana Castro, DDS MSc PhD, Clinical Director of the Department of Periodontology, Catholic University of Louvain, France, Lambert, DDS, PhD, Professor and Director of Periodontology, Oral Surgery and Implant Surgery, University of Liège, Arturo Llobell, DDS, MS, Private Practice Periodontist, Valencia, Spain, and Azim Malik, BDS, MFDS RCSEd, DipPCD RCSI, DClinDent, MPerio RCSEd, Private Practice Periodontist and Implantologist, London, UK.
When teeth are damaged by trauma, decay, or gum disease, the current standard of care involves a multi-stage procedure to restore the patient’s tooth with a prosthetic crown supported by a dental implant. Often, the extraction site is too large for the implant to achieve initial stability through traditional mechanical engagement.
Instead, patients must undergo a costly, complex, and lengthy process, including an initial bone graft procedure, before they can receive a dental implant. Using TETRANITE to stabilize unstable implants will allow for immediate implant placement that otherwise would not be possible until the initial bone graft heals and forms new bone. As a result, TETRANITE® Biomaterial will help reduce the duration and complexity of these dental implant procedures, reduce pain and recovery time for patients, and reduce overall cost of care, thereby providing patients with more access to treatment for tooth loss.
Dr. Alan Pollack, Senior Director of Dental Clinical Operations at RevBio, said, “The approval and successful enrollment of the first 30 patients in this pivotal clinical trial is a watershed moment for RevBio. This clinical trial has the potential to significantly accelerate the adoption of this promising bone adhesive technology in dentistry.”
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