OsseoGuard Flex™ is a resorbable membrane material designed for various oral surgical procedures. It's primarily used in dental implant surgeries and periodontal treatments.
Intended Use
OsseoGuard Flex™ is utilized in several oral surgical contexts, including:
- Augmentation around immediate and delayed extraction sockets.
- Localized ridge augmentation for later implantation.
- Alveolar ridge reconstruction for prosthetic treatment.
- Filling of bone defects.
- Guided Bone Regeneration (GBR) in dehiscence defects.
- Guided Tissue Regeneration (GTR) in periodontal defects.
Description
OsseoGuard Flex™ is a white, nonfriable membrane matrix made from highly purified bovine dermis. Being resorbable, it eliminates the need for a second surgery for removal, which is a significant advantage over non-resorbable membranes. It's sterile, non-pyrogenic, and intended for single use.
Administration
Preparation and Application
- Packaged in a double sterile pouch, the outer pouch should be opened to transfer the inner pouch to a sterile field.
- After exposure of the bone defect, basic surgical procedures are performed.
- The defect can be filled with space-making materials like autologous bone or ceramic materials.
- OsseoGuard Flex™ can be used either dry or hydrated, and can be trimmed to fit the defect.
- It should overlap the defect by at least 2mm and may be fixed in place with sutures or resorbable tacks.
- The mucoperiosteal flap is then sutured over the membrane.
Post-operative Procedures
- OsseoGuard Flex™ is completely resorbable within 6 to 9 months.
- Post-surgery, patients should use an antimicrobial agent like chlorhexidine gluconate and avoid brushing the treated area for two weeks.
- Follow-up visits are crucial for wound evaluation and suture removal.
Contraindications
- Not suitable for patients with allergies to collagen or bovine products.
- Should not be used in cases of acute infections in the oral cavity or in patients with significant systemic diseases.
Warnings and Precautions
- Exercise caution with patients having allergies or significant systemic diseases.
- Not evaluated in pregnant women, children, or in severe defect cases.
- Cannot be re-sterilized or reused.
Adverse Reactions
- Potential complications include infection, swelling, thermal sensitivity, and other surgery-related issues.
Safety
- Complies with international standards for animal tissue sourcing and pathogen inactivation.
- Undergone viral inactivation studies to ensure safety.
Storage
- Store at room temperature (15°C - 30°C), avoiding excessive heat and humidity.
Conclusions
OsseoGuard Flex™ is a significant advancement in dental surgery, particularly for implantology and periodontal treatments. Its resorbability eliminates the need for secondary removal surgery, enhancing patient comfort and reducing overall treatment time. However, careful patient selection is crucial due to contraindications like allergies to bovine products. Its safety and efficacy, backed by rigorous manufacturing standards, make it a reliable choice for oral surgical procedures.
