TODABONE^®

Bioactive Synthetic Bone Graft

Instructions for Use

DESCRIPTION

TODABONE^® is a bioactive, absorbable and synthetic bioceramic so called bioglass, which is composed of elements naturally occurring in bone (Ca, Na, Si, P, O). The specific composition introduces excellent properties to the product, such as bone bonding, osteocunductivity and osteoinductivity. TODABONE^® is intended to fill bone defects of traumatic, pathologic or surgical origin. When implanted in living tissue, the surface reaction results in the formation of a calcium phosphate layer, which is substantially equivalent in composition and structure to the hydroxyapatite from the mineral phase of human bone.

INDICATIONS

The intended use of TODABONE® is to provide a safe and biocompatible bone graft material for oral and dental intraosseous defects. It is used in a manner comparable to autogenous or allogeneic bone grafts.

Main indications are:

– Periodontal / Infrabony defects.

– Ridge augmentation.

– Filling tooth sockets for ridge maintenance following extraction.

– Filling bone defects in oral and cranio maxillofacial surgery.

– Filling bone defects such as cyst or dental granuloma.

– Sinus floor augmentation

– Traumatic defects (sinusotomy, osteotomy, cystectomy, apicoectomy)

CONTRA-INDICATIONS

TODABONE® should not be used in patients with/who:

– Acute or chronic infection at the surgical site.

– Metabolic diseases (diabetes, hyperparathyroidism, osteomalacia,).

– Severe hepatic and renal dysfunction.

– Need chronic anticoagulant therapy.

– Are taking immunosuppressant medication.

– Injecting corticosteroids for a long time.

– Osteomyelitis at the surgical site.

– Vascular impairment at the implant site.

– Have had, or are undergoing irradiation treatment of the graft region.

– Any existing condition or disease that will interfere with good mucosal and bone healing.

ADVERSE REACTIONS

Possible complications are the same as to be expected of autologous bone grafting procedures: post-operative infection, allergic reactions due to the components of product. Complications that may arise as a result of the surgical procedure may include; oral indications-tooth sensitivity, gingival recession, flap sloughing abscess formation, resorption or ankylosis of the treated root; general indications-infection, pain, swelling and complications associated with the use anesthesia.

PRECAUTIONS BEFORE USE

– Check the use-by date and check that the packaging is intact before use.

Implants for which the packaging is open or damaged or for which the use-by date has elapsed should not be used.

– For safety reasons, the implantation of TODABONE® is inadvisable during pregnancy and breastfeeding.

– TODABONE® is intended for single use and should never be reused. Reuse is liable to give rise to pathogen transmission risks and impairment of the physicochemical properties of the implant.

– Existing oral pathological conditions (e.g. Infections) may compromise the results and should be controlled or eliminated prior to the use of TODABONE®. For example, vital bone must be exposed prior to graft placement in cases of chronic local infection or long-term use of sub gingival antibiotics.

– The use of a membrane is recommended in cases where the defect is large or limited bony retention is present. A primary closure of defects, preferably tension free, is highly recommended.
– In larger defects, a mixture of autogenous bone, allograft bone or bone marrow with TODABONE® may improve new bone formation.

– TODABONE® is not intended to be used in immediate load bearing applications. In augmented areas, a mechanical loading or insertion of endosseous implants (late implantation) should not take place for at least 5-6 months after grafting. For implants following sinus elevation, a period of about 6 months for osseous integration should be allowed.
– TODABONE® must not be used to gain screw purchase or to stabilize screw placement. Instrumentation used in conjunction with TODABONE® must gain purchase in the host bone. Standard postoperative practices for the treatment and rehabilitation associated with bone grafting must be strictly followed.

– Do not apply excessive force when implanting TODABONE® at the surgical site.

– Use this product in well vascularized bone.

– Product should be protected from contamination due to touching patient’s tongue or flowing in saliva.

INFORMATION FOR THE PATIENT

– The patient should be informed by the surgeon of the potential risks and undesirable effects resulting from the implantation. His agreement is needed for the surgery to be performed.

– The surgeon should inform the patient receiving this device that the success of the implantation depends on his behaviour.

– The patient should inform his surgeon of any event which would compromise the proper integration of the implant and should undergo regular post-operative examinations.

PREPARATION

– Do not place TODABONE® in the dry as-received state. TODABONE® could be mixed with normal saline solution, autologous bone, patient blood or PRF (Platelet-Rich Fibrin).

– Typically, the flat end of a sterile spatula can be used for approximately 10-15 seconds to mix the TODABONE® with the solution. The mixed material may be delivered to the surgical site using the spoon end of the spatula, or it may be delivered after placing the material back into the delivery syringe. TODABONE® will remain in a moist workable condition for 2-3 minutes following mixing. TODABONE® does not set like cement. 

– When placing the graft material, pack it with a compress moistened by normal saline solution. Excess filling is recommended.

– In order to enhance the host site vascularization, heighten the host cortical bone walls.

– Combining TODABONE® with any medication during surgery is carried out under the surgeon’s responsibility.

– The Good Aseptic Practices and the general principles for drug treatment of the patient must be observed while using TODABONE®.

– Standard Postoperative Practices for the treatment and rehabilitation associated with bone grafting must be strictly followed.

– Routine surgical procedures should be used to expose the surgical site. Once exposed, eliminate all granulation or necrotic tissue at the defect site. Irrigate the defect with sterile saline or water and evacuate the excess. In order to enhance the formation of new bone, TODABONE® should only be in direct contact with well vascularized bone. Cortical bone should be mechanically perforated.

– Intra-marrow penetration is useful to insure some bleeding from the host bone, which provides a supply of osteogenic material to aid in bone regeneration.

– The amount the graft material needed is based on the defect size and the procedure & is determined by the judgment of the clinician.

SUCCESSFUL PLACEMENT TECHNIQUE ADVICE:

– When placing the graft material, do not compress the material into the site or blot away the blood /moisture in the placed graft material.

– After placement of the TODABONE®, ensure primary closure of the soft tissues over the graft site. Resorbable or nonresorbable membranes may also be used to achieve closure. For periodontal applications, a synthetic 3.0 or 4.0 suture material using a vertical mattress or interrupted closure is recommended (or surgeon’s preference). As is the case with any particulate graft procedure, primary closure of the surgical site is essential.
– Appropriate postoperative antibiotic, analgesic and home care regimen should be prescribed. The oral or periodontal patient should be cautioned against chewing on or brushing the area for at least 1 to 2 weeks, or as long as the clinician deems necessary. Antibacterial rinses should be used during this period.

STERILIZATION, PACKAGING and STORAGE:

– Sterile device is packed in a PETG small cup as a primary package and a secondary package of PETG larger cup and sterilized by Ethylene oxide(EO). Sterility is guaranteed until the indicated expiration date, if the package is intact and not opened.

– Re-sterilization is not allowed.

– This product is to be handled or implanted by trained qualified persons having read these instructions for use.

– Excess material cannot be saved for later use due to risk of contamination and infection.

– Shelf life is 5 years.

– Store in a dry place below 25°C.

PRESENTATION: