NCT06059898

Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration

A Randomized Clinical Study Comparing the Bioresorbable Magnesium NOVAMag® Membrane With the Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Botiss Medical AG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The NOVAMag® membrane is a medical device approved in the EU, and is a completely resorbable and biodegradable metal membrane. This medical device is used in the treatment of bone defects in the oral cavity. The membrane ensures sufficient stability of the bone augmentation material and provides a barrier to the soft tissue. This enables new bone to form in the defect space and for the subsequent placement of dental implants. In this clinical trial, the NOVAMag® membrane is compared with the Jason® collagen membrane, another medical device for supporting bone regeneration, with the aim of demonstrating the non-inferiority in terms of radiographically measured volumetric bone gain of the NOVAMag® membrane to the comparator membrane.

Detailed description

GBR is a well-established surgical procedure based on the use of tissue barriers to separate the void of hard tissue defects from overlying connective tissues, thus preventing the ingrowth of soft tissue into the defect site resulting in improved bone regeneration. GBR is used both with and without different bone graft materials, such as allografts, xenografts and synthetic substitute materials, which have shown comparable results to those obtained with autologous bone in localized horizontal defects. The barrier membranes used in GBR can be produced from animal (bovine, porcine), human (allogenic) and synthetic biomaterials. Due to their origin, composition and manufacturing process, each biomaterial performs differently in the human body, with their own associated advantages and disadvantages. Non-resorbable membranes (primarily made from PTFE \[polytetrafluoroethylene\] and titanium\] can offer mechanical reinforcement to protect the defect void, as well as maintain a continuous barrier function until they are removed. The main disadvantage of these membranes is the necessity of a second surgical procedure for their removal. In response to this disadvantage, resorbable membranes have been developed with porcine collagen membranes considering the standard product for use in GBR. These collagen membranes produce excellent biocompatible results, but they lack mechanical stability, especially for use in larger augmentation sites. To address the aforementioned issues of both the resorbable and non-resorbable membranes, botiss biomaterials GmbH has developed the NOVAMag® membrane, which has recently received CE approval. The NOVAMag® membrane is a resorbable, biodegradable magnesium membrane. The material properties of the pure magnesium membrane culminate into a design that has a mechanical stability not provided by other resorbable membranes. Despite being resorbable, the membrane maintains a separation of the soft and hard tissues until the bony defect has been repaired (data on file at botiss). The ability of membranes to resist collapse into the defect void and maintain space for the ingrowth of new bone is viewed as an important aspect for producing a successful regenerative outcome. This is most easily achieved by using a strong material that can resist the external pressures of the overlying soft tissue and the forces experienced during function. The risk of collapse tends to be higher for resorbable membranes due to inferior mechanical properties. Mechanical testing performed by botiss have proven that the magnesium membrane is self-supporting and substantially stronger than other resorbable collagen membranes. Therefore, the risk of collapse into the defect void, as reported for collagen membranes, could potentially be prevented by using the NOVAMag® membrane. The aim of this randomized clinical study is to compare a bioresorbable magnesium NOVAMag® membrane with the collagen Jason® membrane in patients requiring guided bone regeneration.

Conditions

• Guided Bone Regeneration (GBR)
• Ridge Augmentation
• Periodontal Bone Defect

Interventions

Type	Name	Description
DEVICE	GBR surgery including membrane placement	After the application of local anesthesia, an incision of the mucosa will be performed and the flap will be elevated. The flap closure line should not be directly over the defect, but away from the defect site to prevent wound dehiscence. The bony defect will be thoroughly cleaned and, in some cases, activated by drilling small holes in the cortical bone to increase blood flow into the bone graft. Bone substitute will be inserted, the membrane will be adapted and fixed, and the flap will be sutured
PROCEDURE	Biopsy	After a healing period of 6 months, at the implantation site, a biopsy is taken from the site of dental implant insertion for further analysis of bone regeneration

Timeline

• Start date: 2022-04-08
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-09-29
• Last updated: 2023-09-29

Locations

5 sites across 3 countries: Austria, Denmark, Italy