Clinical studies

Clinical Studies: Oral & Maxillofacial Application Area

Bone substitutes are commonly used in the treatment of oral and maxillofacial bone defects to prevent bone loss and to regenerate bone tissue. Typical applications in the oral & maxillofacial area for bone substitutes are filling of bone cavities, for instance after tooth or cyst removal, or reconstruction of bone tissue in sinus lifts. The use of bone substitutes in this application contributes both to functionality and cosmetics by preventing bone loss in the mandible and ensuring successful tooth implant attachment.

The clinical study: ClinicalTrials.gov ID: NCT04719624, focused on comparing the efficacy and usability of Adaptos® granules (two different compositions) in an alveolar ridge preservation model with the main comparison between graft filled tooth extraction sockets and non-filled sockets. The study has been closed with 71 patients operated.

The assessment of the radiological data is currently ongoing, and the results of the analysis will be reported to public registry (clinicaltrials.gov) as soon as they are available. The preliminary view of the data has not raised any concerns related to investigational device safety.

Link: Study Details | Novel Porous Bioceramic Material as a Bone Substitute | ClinicalTrials.govv


Clinical Studies: Orthopedics Application Area

The innate capacity of bone tissue to heal after trauma without scar formation is unique compared to other tissues. Yet bone tissue is the second most common tissue transplant after blood transfusion. In fact, a bone graft or a bone substitute is used in over 4 million operations every year to treat more severe bone defects.

The available bone grafts and bone substitutes are still missing an optimal synthetic material that can compete with autograft bone with respect to usability, efficacy, and safety.  Adaptos® bone graft is designed to support and aid bone formation when the damaged tissue needs additional support to heal and regenerate.

The clinical study: ClinicalTrials.gov ID: NCT05570760, is focused on evaluating Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy (HTO) model.

The randomized, controlled, partially blinded, multi-center trial is about to start operations with patients in 2024 spring. The primary objective of the study is to evaluate the efficacy and safety of Adaptos®Ortho Wedge in HTO application by comparing the bone regeneration of the osteotomy defect between three arms: augmentation with Adaptos®Ortho Wedge, augmentation with a predicative device, or non-augmented defect. The study is sponsored by Biomendex.

Privacy Policy / Tietosuojaseloste of the Study can be found here

Link: Study Details | Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy | ClinicalTrials.govv