Open Healing Concept - Dual Membrane for Bone Regeneration

Purpose and goal

Guided Bone Regeneration (GBR) is a method where a membrane is used for the treatment of bone defects. In the current standard GBR protocol, complete soft tissue coverage of the membrane is required for successful outcome. The Open Healing Concept is a paradigm shift: It allows intentional exposure of the membrane to the oral cavity with maintained function. The aim of this project is to verify in vivo bone formation and infection control using the Open Healing Concept. Bone formation and infection control has been shown in the finished subprojects. Clinical verification is initiated.

Expected results and effects

Successful outcome of the project would open for new GBR treatment protocols that require fewer surgical procedures and results in less discomfort and lower cost for the patient. It would also lead to reduced frequency of complications. The finalized projects have all shown successful outcome. They form the basis for the clinical study that is currently starting up. A successful outcome in the clinical study would be instrumental in the internal regulatory approval and market release of Neoss membranes for Open Healing.

Planned approach and implementation

The project is divided into 4 subprojects. Project 1 is a clinical study on dental plaque formation on membrane surfaces in human volunteers. Project 2 is an in vivo analysis of the Open Healing Concept to gain knowledge of treatment outcome and tissue interactions with the membrane surfaces. Project 3 is the initiation of a pilot clinical trial. Project 4 is business development, to evaluate the patentability and the commercial value. All subprojects have been initiated according to plan. Project 1, 2 and 4 have been completed with successful outcome. Project 3 is currently starting up.