Orthocell Striate+ dental implant study delivers 98.6% success rate

Regenerative medicine company Orthocell has announced the results from its Striate+ dental implant post market clinical study. The study showed that dental implant procedures using the Orthocell Striate+ dental membrane for Guided Bone Regeneration (GBR), resulted in a 98.6% implant success rate.

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.

Orthocell Striate+
(Image: BioHorizons)

Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of bone and soft tissue injuries. Striate+ was the first product approved for dental GBR applications, is cleared for use in US FDA (510k), Australia (ARTG) and Europe (CE Mark) and is distributed globally by BioHorizons Implant Systems Inc.

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 study results have been submitted for presentation at the upcoming European Association for Osseintegration (EAO) annual meeting on 24-26 Oct 2024.

According to the company, 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,” said chief investigator and dental surgeon, Professor Luongo.

The study aimed to determine the effect of Striate+ collagen membrane on patient-related systemic factors, as well as implant-related and procedure-related factors of peri-implant MBL following GBR and implant placement. Data were obtained from 99 patients receiving at least one dental implant and GBR procedure using Striate+ dental membrane between July 2018 and December 2023. Patients in the study varied in age, gender, smoking status, medical history, implant brand, implant size, surgical procedure and void filling materials used. The MBL was recorded using radiographic data at implant placement, re-entry surgery and follow-up visits. Influencing factors of ΔMBL between visits were further analysed.

A total of 143 implants, placed in 99 patients (44 [44.4%] men and 55 [55.6%] women), were included in the study analysis. The mean age was 64.04 ± 11.76, ranging from 23-84 years old. The median follow-up period was 21 weeks, ranging from 6-230 weeks. Mean MBL values at implant placement, re-entry surgery and last follow-up visit were 0.56 ± 0.66, 0.80 ± 0.69, and 0.94 ± 0.75, respectively. Of the 143 implants, 127 (88.8%) implants have simultaneous GBR and implant placement. One hundred and twenty-six (88.1%) implants have MBL values within the normal physiological limits, while only 2 (1.4%) failed due to peri-implantitis, resulting in an implant success rate of 98.6%. No contributing factors associated with ΔMBL were identified by multivariate regression analysis in the study.

According to Orthocell, 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. The addressable market for the Orthocell Striate+ product is estimated to be worth more than US$700m per annum1 in which Orthocell is already growing its revenue.

Moreover, GBR is a highly successful approach for restoring dental bone defects alongside implant placements, with success rates often higher than 70%.2 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.

Orthocell’s portfolio of products include CelGro platform of collagen medical devices which facilitate tissue reconstruction and healing in a variety of dental and orthopaedic reconstructive applications.

Footnotes

1 Addressable market estimate was developed by the Company using reports from US healthcare databases and referenced papers of studies conducted both within and outside the US.
2 Orthocell systematic literature review 2023. Data on file

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