Description:

Octabone® is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material. Octabone® is packaged and sterilized using gamma irradiation. The shelf life is 3 years for Octabone® and Octabone® block and 2 years for Octabone® Syringe. Octabone® has a highly cancellous structure similar to human bone demonstrated under high magnification.

 

Indications (Intended use):

Octabone® is intended for use in bone regeneration and augmentation of oral and maxillofacial bone defects with or without products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

- Alveolar ridge defects.

- Sinus Augmentation.

- Extraction defects (or alveolar ridge preservation or socket preservation).

- Periodontal defects.

- Peri-implant defects.

- Apicoectomies.

- Cystectomies.

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Usage:

Practitioners should follow surgical principles according to standard medical or dental practice.

- Remove any soft tissue or granulation tissue carefully and expose fresh bone.

- Completely soak Octabone® with saline solution or the patient’s blood product before application.

1. Octabone®: Fill the defect with prepared Octabone® using a sterilized spatula or surgical spoon.

2. Octabone® Block: Shape Octabone® Block to fit the bone defect. The block may be adapted to the desired size and shape with instruments such as scalpels or rotating burrs and placed into the bone cavity. Fill the defect with prepared Octabone® and stabilize it using a horizontal matrix suture technique.

3. Octabone® Syringe: After unscrewing the top cap, completely soak Octabone® by pulling the plunger of the syringe to suck saline or the patient's blood. Unscrew mesh cap and press the plunger and apply Octabone® directly into the defect site.

- Avoid applying excessive pressure on Octabone® particles to maintain its multiporotic nature. Breaking Octabone® down into smaller pieces may adversely affect the surgical site’s healing rate.

- Apply protective membrane over applied Octabone® as necessary.- Do not overfill defects.- Do not leave defects open.

- Surgical dressing may be placed over the wound for the minimum duration determined to be necessary by the clinician to facilitate control of bleeding and wound healing.

- 6 months healing time prior to implant placement is recommended, but the operator should evaluate and make his or her own determination.

 

 

Contraindications:

Local: Octabone® should not be used in sites with active infections or uncontrolled bleeding.

General: Octabone® should not be used in patients who cannot medically tolerate surgery (e.g. cannot tolerate anesthesia, active heart condition precluding safety of surgery).

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Precautions:

Octabone® should only be used by trained dentists or oral surgeons.

Octabone® should be used with special caution in patients with the below conditions:

1. Local precautions:- Osteomyelitis near the bone defect site.

2. General precautions:

- Blood dyscrasias.- Heavy tobacco use.- History of radiation therapy.

- Metabolic diseases such as diabetes, thyroid function disease (hypo/ hyperthyroidism), advanced liver or kidney disease, osteoporosis.

- Undergoing chemo-sterydotherapy (chemotherapy or steroid therapy).

- Autoimmune diseases.

- Medical consultation prior to use is recommended at the discretion of the practitioner.

3. Additional precautions:

- Safety and efficacy in patients without mature skeletal systems, or pediatric patients, and in patients who are pregnant or lactating is not known.

- Various types of bone graft products can be used together (e.g. xenograft with allograft or autologous bone). Only dentists and oral surgeons who are familiar with such techniques should use these approaches.

- No data has demonstrated superior efficacy for either particle size. Clinicians should determine the most appropriate particle size for each case based on the circumstances particular to that case.

 

 

Storage and Handling:

- Store in dry conditions at 15-25℃.

- The sterile packaging should be opened only at time of use. Do not use if the sterile packaging is damaged or opened prior to time of use.

- Single use only. Do not re-sterilize the product.

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Adverse reactions:

Common surgical complications may include inflammation, fever, edema, pain, bleeding, loss of function, decreased bone growth.

 

Caution:

Common surgical complications may include inflammation, fever, edema, pain, bleeding, loss of function, decreased bone growth.

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Presentation:

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