Beta TCP Bionnovation
Beta Fosfato Tricalcio – Synthetic
DESCRIPTION AND ACTION FOUNDATIONS
phase (Ca3(PO4)2) Beta-Tricalcium Phosphate (ß-TCP) is a synthetic and
reabsorbable granulated ceramic, made from Calcium Hydroxide (Ca(OH)2),
Phosphoric Acid (H3PO4) and Sucrose (C12H22O11). It is used as a matrix to
replace or modify the bone tissue, since it has an identity, in terms of
composition, with the bone matrix and allows restoring that tissue through the
and biocompatible material, being partially reabsorbed between 6 and 15 weeks
after the implant depending on the porosity, chemical structure and size of the
particle. The resorption of Beta TCP are organized by hydrolytic mechanism that
guides the physical disintegration.
phosphate ceramics have deserved a place of high light among the so-called
bioceramics due to their lack of local or systemic toxicity, absence of foreign
body response or inflammations and apparent ability to link itself to the host
tissue. Such positive characteristics maybe explained by the chemical nature of
those materials, which since they are basically formed bycalcium and phosphate
ions, they actively take part in the ionic balance between the biological fluid
and the ceramics.
physico-chemical similarity of the Beta TCP with bone tissue facilitates the
process of recognition and osteoblast signaling that favors the remodeling
process and new bone formation. The reabsorption of the material representing
that degradation is caused by dissolution, which depends on the material’s
solubility product and the local pH in the physiological mean, through the
physical disintegration in to smaller particles and, also, through biological
factors, such as phagocytosis, the presence of leukocytes and of chemical
mediators that cause a reduction of the local pH.
The application of
Beta Tricalcium Phosphate (ß-TCP) allows restoring the bone tissue through the
INDICATIONS AND PURPOSE OF USE
Beta TCP is a synthetic bioceramics,
elective for regenerative techniques in Periodontology, Implantology,
Orthopedics or medical and dental surgeries that require bone neoformation. Is a
biomaterial used in bone grafting procedures, in reconstruction in bone walls
defects, traumatic or degenerative, sinus floor elevation, periodontal or
alveolar bone filling and osteotomies, as well as the preservation and
preparation of the implant site. In case of medical procedures are used in
orthopedics and Traumatology for cases such as muscle-skeletal tumors fixes,
rachimedular and cervical spine trauma. In the event of medical procedures,
they are used in orthopedics and traumatology in cases such as muscleskeletal
tumors corrections, spinal cord traumatisms and cervical spine.
PRECAUTIONS, RESTRICTIONS, WARNINGS
– as long as maintained the integrity of the packaging, period of validity and
use only is the responsibility of the dentist or doctor their prior training to
use this product. Only qualified professionals with expertise in surgical
techniques and procedures necessary for proper use of the product should make
use of TCP Beta. The use of incorrect surgical techniques may cause discomfort
as painful sensation, hypoesthesia, edema.
RESTERILIZE AND REPROCESS – If resterilized or reprocessed may occur change at
the physical chemical properties and crystallinity levels of Beta TCP causing
foreign body reaction.
REUSE – If reused or used with expired validity, may cause irritation,
infection, inflammation and other adverse events, compromising the health and
safety of the patient. Bionnovation does not recommend reuse, re-processing or
resterilization, discard it as current legislation for medical waste.
use of the product with surgical techniques and inadequate biosecurity
conditions may damage the patient leading to unsatisfactory results.
sterilize the tools before using them.
clinical and radiographic evaluation must be done prior to surgery, to help the
correct treatment planning. Determination of bone quality and quantity, repairs
and anatomical structures and analysis of neighbouring teeth.
In all surgeries involving beta TCP particles
must be observed proper techniques used for asepsis and antisepsis.
abuse of alcohol, tobacco, drugs, steroids or lack of proper oral hygiene can significantly
impair the success of the treatment.
All potential adverse
effects as dehiscence, inflammation, bone loss, hemorrhage, must be previously
informed to the patient.
It is supplied
in sterile condition and once opened should be used in aseptic conditions. Should
always work with sterile fields, appropriate instruments to the procedure and
in good condition in order to eliminate sources of infection and damage to the
Beta TCP should
be used only for the purpose for which it is intended.
complications impossible to be controlled, tissue inflammation or evidence of
infection is recommended the immediate removal of the material.
Beta TCP is
provided in sterile double packaging (25 kGy gamma radiation). Provided that
the package integrity is not compromised in any way, it will save the sterile
product up to 3 years from the date of sterilization.
There are no
restrictions as to maximum amount of product that can be deployed. The amount
will be determined by the professional after analyzing the size of the surgical
should evaluate the indication in patients who are carriers of diseases or are
making use of medication that may alter the repair metabolism.
The remainder of
the packaging material should not be reused, reprocessed or resterilized,
discard it mischaracterized as current legislation for medical waste, do not
discard contaminated products in household waste.
In cases of
adverse effects occurring in patients, the responsible must contact immediately
with the SAC Bionnovation (Customer Service) by the number 0800 707 3824 or by
e-mail firstname.lastname@example.org. The
Bionnovation Biomedical Products is responsible for notifying the ANVISA
(Health Surveillance Agency) about the relevant occurrences according to
internal technovigilance procedure.
TCP was developed in order to prevent that its use does not compromise the
clinical condition of patients as well as their safety.
Note: we recommend that the identification
stickers that come with the product be attached to the patient’s documentation:
clinical record of the patient, the report delivered to the patient, product
sales invoice, vendor control and control of the surgeon in charge, ensuring
the complete traceability of the product.
Beta TCP, as
well as all the other biomaterials, should not be placed on an existing active
infection or in any other degenerative disease that might affect the
It must not be
utilized in patients that are notable, under the clinical point of view, to be
submitted to a medical or odonthological intervention. Such as, for example, in
patients with uncompensated diabetes.
Beta TCP is not
indicated for odontopediatric patients.
contraindicated for procedures different from those recommended in item "Use
- Beta TCP should not
be exposed to the external medium.
CONDITIONS FOR THE PRODUCT’S STORAGE AND TRANSPORTATION, CONSERVATION AND/OR
Transportation: Transport and store the product away from direct sunlight, and
from heat or humidity sources. Keep it at a temperature between -5°C
and 45°C and free from humidity. If the
indicated temperature or humidity limit is exceeded, please discard the
product. Keep the packaging sealed until its utilization time. In the case of a
violated packaging or if the validity term has expired, please discard the
verify the integrity of the same before using it. Do not use it if the sterile
package has been opened, or if it’s damaged, or if the sterilization validity
date has expired in order to avoid possible contamination. Discard any
mischaracterized product according to the applicable legislation for hospital
waste, or return the damaged packages to the factory, including the device.
- Conservation and
Handling: In case of any alteration in the Beta TCP characteristic that might
have mischaracterized it, please discard it according to the applicable
legislation for hospital waste, or return the damaged packages to the factory,
including the device.
The bone region
to receiving the biomaterial should be exposed and curetted, decorticated or
pierced for exposure of organic matrix and removed all compromised tissue. To
facilitate application to the surgical site may be used conventional
instruments such as curettes, spatulas, plastic or metal applicators.
The product is
bonded by blood as it is being applied. The product should NOT be moistened in
saline solution. For being a too thin biomaterial with easy flowing, the dentist
or doctor in charge should evaluate the implant, controlling homeostasis to
avoid product flow.
bone, collected during surgery, in order to facilitate the process of new bone
maximum contact between the bone replacement material and the receiver bone, with
complete filling of space and good compression.
the flap on the grafted area and make sure that the coverage of the surgical
site is full. Suturing in order to stabilize the area, but without tension.
6. There can be no
exposure of the biomaterial, because it is critical to surgical success and to
avoid contamination of the area.