OsseoSeal Membranes

Description

OsseoSeal Indications:

OsseoSeal is recommended for:

• Simultaneous use of GBR-membrane (OssGuide) and implants;
• Augmentation around implants placed in immediate extraction sockets;
• Augmentation around implants placed in delayed extraction sockets;
• Localized ridge augmentation for later implantation;
• Alveolar ridge reconstruction for prosthetic treatment;
• Aid regeneration of bone defects after root resection, cystectomy, removal of retained teeth;
• Guided bone regeneration in dehiscence defects

OsseoSeal Resorption time

In a controlled study, OssGuide maintained its contour until 8 weeks, lost most of its integrity after 12 weeks, and disappeared by biodegradation at 24 weeks.

Substantially Equivalent to  BIO-GIDE®
The FDA concluded in the 510K submission for Ossguide (K200623) that it is substantially equivalent to Bio-Guide, the predicate device used in the 510K submission. If you read the submission, it is noted that in many respects OsseoSeal is identical to Bio-Gide. The primary difference is that Bio-Guide is made from Porcine peritoneum, while OsseoSeal is manufactured from Porcine pericardium.

OsseoSeal Placement

OsseoSeal can be placed either dry or hydrated. OsseoSeal can be trimmed to the size and shape of the defect in a dry or wet state using scissors. A piece of sterile Tyvek may be used as a template for membrane sizing and trimming. OsseoSeal should overlap the walls of the defect by at least 2 mm to allow complete bone contact and to prevent gingival connective tissue invasion below the material. The membrane may be secured in place with sutures, tacks, or by means of sufficient contact with the mucoperiosteal flap to avoid displacement and micro motion during healing. To facilitate proper healing, ensure that there is tension-free primary closure of the soft tissue flap covering the membrane

Comparison of Tensile Strength with “other product”

Osteoblast Cell Adhesion Test

After the cultivation by U-2OS osteoblast cell line it is confirmed osteoblast cell line, it is confirmed by SEM that bone cell is well adhered and replicated on adhered and replicated on surface of OsseoSeal in day 3.

Bone Volume, Bone Intensity Test (Rat’s Calvarial Bone Defect Model)
In reviewing the result of micro CT in rat’s calvarial bone defect models, after 12 weeks from the operation, a bone volume of OsseoSeal is increased up to 93.15 and bone intensity is up to 1.68. In reviewing the opinion of tissue inspection, after 12 weeks from the operation, OsseoSeal shows perfect bone generation

Clinical Application of OsseoSeal