Regenerative medicine company Orthocell Limited (ASX: OCC) has obtained “outstanding” results from the Striate+ dental implant post market clinical study.
The Study showed that dental implant procedures using Orthocell’s Striate+ dental membrane for Guided Bone Regeneration (GBR), resulted in a 98.6% implant success rate.
The Striate+ Study followed on from the Post-Market Clinical Follow-up (PMCF) study, a key component of the clinical data package for re-certification of EU market approval under the new European Medical Device Regulations (MDR).
The Striate+ Study aimed to further investigate the effect of the Striate+ collagen membrane on patient-related systemic factors, as well as implant and procedure related factors of peri-implant Marginal Bone Level (MBL) following GBR and implant placement.
The result displayed that a desirable level of bone formation and stability was achieved in all areas, demonstrated by the high rate of treatment success.
The results follow a successful collaboration between Professor Giuseppe Luongo at the Department of Neuroscience and Reproductive and Odontostomatological Science, University of Naples Federico II, Naples, Italy and Professor Minghao Zheng at the UWA Medical School, University of Western Australia.
“Striate+ is a best-in-class dental membrane that facilitates the highest quality bone and tissue repair. Predictable and high-quality bone regeneration is of utmost importance to deliver functional and aesthetically pleasing outcomes for patients. We are delighted to share this compelling real-world data,” chief investigator and dental surgeon, Professor Giuseppe Luongo, said.
Guided bone regeneration
Dental implants are an effective and rapidly growing area of orthodontic treatment. Often patients lack sufficient bone volume to adequately secure the dental implant and, as a result, require GBR as part of the dental implant procedure.
GBR is a highly successful approach for restoring dental bone defects alongside implant placements, with success rates often higher than 70%. However, treatment success can be affected by a variety of patient factors, such as smoking, other medical conditions, or peri-implantitis, all of which can affect the amount of bone regeneration needed to stabilise the dental implants.