BONEFILL FINE: 0.10-0.60mm (Fine)-0.5g • 0.5 cc (Cortical)
BONEFILL MEDIUM: 0.60-1.50MM (MEDIUM)-0.5G • 0.5 cc (Cortical)
BONEFILL LARGE: 1.50-2.50mm (Large) - 0.5 g • 0.5 cc (Cortical)
INSTRUCTIONS FOR USE
NOT FOR SALE IN CE COUNTRIES
Bonefill – Bone Graft Materials, is a natural mineral bone
removed from bovine femur bone, is an implantable dental biomaterial and used
in reconstruction of bone defects where you want to remodel or new bone
Bonefill – Bone Graft Materials are recommended to fill bone
defects and volumetric increase at the following situations: increase /
reconstruction of alveolar ridges, post extraction void filler, filling
cavities produced by surgical interventions post cysts treatments, granulomas
and other lytic pathology; buco -maxilo-facial and dental, preparing the
implant site and bone dehiscence filler, in addition to the maxillary bone
grafts in periodontology and can be used in the support to membrane for guided
AND ACTION FOUNDATIONS
Bonefill – Materials for bone graft, natural bone
mineral extracted from bovine femur, is an implantable dental biomaterial used
in bone failure reconstructions where remodelling or bone neoformation is
The purified osteoconductive mineral structure is
produced from natural bone through a multiphase purification process, complying
with the safety regulations established by the control agencies. The fresh bone
is crushed, receiving a sequence of baths that solubilize the organic
structures such as, for example, remaining cells, fibers and proteins, with
only the mineral portion remaining this way in order to avoid the induction of
possible immunogenic processes in the body. The products constituted by
mineralized bovine bone is has an expected incorporation of 6 to 9 months.
Due to the natural origin, Bonefill – Materials for
Bone Graft is comparable to the mineral and morphological structure of the
human mineralized bone, it is biocompatible, does not present cytotoxicity,
acute systemic toxicity, sub-chronic toxicity, carcinogenicity and it is not a
sensitizing product (ISO 10993-1).
Bonefill – Materials for bone graft, are available
in the following models: Bonefill and Bonefill Mix in granule form and Bonefill
Porous, available in granules and blocks. The granules are presented in glass
vials packed in blister and box and the blocks are packed in blister and box.
Bonefill is produced through the decalcification
process of the cortical portion of bovine bones, Bonefill Porous is produced
through the same decalcification process applied to the spongy portion of
bovine bones and Bonefill Mix is produced through the decalcification process
applied to the spongy and cortical portion of bovine bones (approximate ratio
The mineralized inorganic bone matrix of the
Bonefill has a porous macro and micro structure similar to the human cortical
and spongy bones. In granulate form, Bonefill, Bonefill Porous and Bonefill Mix
act as osteoconductive mechanism promoting bone growth and regeneration. With
time, the Bonefill is partially remodelled through the action of osteoclasts
and osteoblasts, being a viable alternative to autologous bone in defects
suitable for its use and indication. In Bonefill Porous, due to the high number
of connection pores and the natural composition, there is the formation and
growth of new bone at the implant site. Bonefill Porous block is incorporated
in the receiving bed through a bone consolidation mechanism comparable to the
biological principles of the consolidations of fracture, obtained through the
formation of new bone connected to the receiving bone /implant interface.
AND PURPOSE OF USE
materials for bone graft is recommended for filling of bone defects and for
volumetric increase in the following situations: increase/reconstructions of
alveolar crests, filling of post-extraction cavities, filling of cavities
produced by post-surgery treatment interventions of cysts, granulomas and other
lytic, oral and maxillofacial and dental pathologies, preparation of implant
and filling sites of bone dehiscence, besides bone grafts in maxillary sinuses
and in the periodontal area it can be used in filling bone defects and to
support the membrane during guided bone regeneration.
– as long as the integrity of the pack, expiry date and storage conditions are
PROFESSIONAL USE – the prior qualification for use of this product is under the
responsibility of the dentist. Only skilled professionals with knowledge of
surgical techniques and the necessary procedures for the appropriate use of the
product should make use of Bonefill – materials for bone graft. The use of
incorrect surgical techniques may cause discomfort such as painful sensation,
hypoesthesia and/or edema. The size of the particles should not be changed.
AND REPROCESSING IS FORBIDDEN – If re-sterilized or reprocessed, change in the
physical and chemical properties and crystalline levels of Bonefill – materials
for bone graft may occur, causing foreign body reaction.
IS FORBIDDEN – If reused or used after the expiry date, the sterilization and
functioning are no longer guaranteed, and it may cause irritation, inflammation
and other adverse events, affecting the health and safety of the patient.
Bionnovation does not recommend the reuse, reprocessing or re-sterilization; dispose
according to the effective legislation for hospital wastes.
use of the product with inappropriate surgical techniques and biosafety can
affect the patient, leading to dissatisfactory results.
sterilize the instruments before using them.
clinical and radiographic assessment should be performed prior to the
installation surgery to help the correct planning of the treatment.
Determination of bone quality and quantity, repairs and anatomical structures
and analysis of the neighbouring teeth.
all operations involving Bonefill – materials for bone graft, the appropriate
asepsis and antisepsis techniques should be observed.
abusive use of alcohol, tobacco, drugs, corticoids or lack of appropriate oral
hygiene can significantly compromise the success of the treatment.
All the potential adverse effects
like dehiscence, inflammation, haemorrhage, should be previously informed to
It is supplied in sterile state
and after opened it should be used under aseptic conditions. Always work with
sterile fields and instruments appropriate for the procedure and in good state
of conservation in order to eliminate sources of infection and damages to the
Bonefill – materials for bone
graft should only be used for the purpose for which it is intended.
In the case of complications that
are impossible to control, inflammations of the tissue or evidence of
infection, the immediate removal of the material is recommended.
Bonefill – materials for bone
graft is supplied in a double sterile pack (Gamma Radiation 25 kGy). As long as
the integrity of the pack is not compromised in any way, it will keep the
product sterile for up to 3 years as from the date of sterilization.
There are no restrictions
regarding the maximum quantity of product that can be implanted. The quantity
will be determined by the professional after analysing the size of the surgical
The surgeon should assess the
indication in patients with diseases or that make use of medication that may
alter the repair metabolism.
The remaining packaging material
should not be reused, resterilized or reprocessed, dispose of it featureless
according to the effective legislation for hospital waste, not disposing
contaminated products in common waste.
In cases of adverse effects on
the patient, the professional responsible should immediately contact SAC
Bionnovation (customer service) on 0800 707 3824 or e-mail firstname.lastname@example.org.
Bionnovation Produtos Biomedicos is responsible for notifying ANVISA (National
Health Surveillance Agency) of relevant occurrences according to the internal
Bonefill – materials for bone
graft was developed to prevent its use from compromising the clinical condition
and safety of patients.
The surgeon is recommended to
keep a follow-up report of the evolution of the case together with the results.
All the bone substitutes of
bovine origin of the Bonefill – materials for bone graft line are manufactured
with animal bones from herd tracked by the SISBOV system. According to the
geographical risk classification issued by the International Zoosanitary Code
and by the Scientific Steering Committee of the European Community (SSCEC
August 2005), Brazil is free from Bovine Spongiform Encephalopathy (BSE).
However, according to ordinance 516/97, even with Brazil declaring to be free
from Bovine Spongiform Encephalopathy, and the processing to which the products
are subjected are known to be efficient in the inactivation of the causing
agent of BSE and the animals used for the production of the Bonefill –
materials for bone graft line are registered in the Brazilian bovine and
bubaline identification and certification system - SISBOV, all products of
bovine origin, even if remote, have the risk of BSE transmission. In cases of appearance
of symptoms of Creutzfeldt – Jakob Disease (CJD), the health professional
should notify the health authority.
We recommend attaching the
adhesive identification labels supplied with the product to the patient’s
documentation: patient clinical record, report submitted to the patient, sales
invoice of the product, supplier control and control of the surgeon
responsible, ensuring the complete traceability of the product.
Bonefill – materials for bone
graft does not completely substitute and does not have the osteogenic
properties of the autologous bone. Therefore, it should be used in bone defects
that promote suitable nutrition to the graft in order for its osteoconductive
activity to take place.
The professional is recommended
to check the general health condition of the patient, observing situations and
pathologies that may lead to a surgical risk and reduced potential of success
in the bone formation. E.g.: Uncontrolled metabolic dysfunctions like diabetes,
osteomalacia, thyroid dysfunction, severe liver or kidney failure, patients
with prolonged use of corticoids, autoimmune diseases, patients subjected to
radiotherapy, and heavy smoking.
To ensure the regeneration of the
bone, Bonefill – materials for bone graft should only be implanted in vital
bone tissue and in direct contact with the host bone. It is recommendable to
use barriers or membranes over Bonefill – materials for bone graft, complying
with the recommendations of the bone regeneration techniques.
For extensive defects, the
addition of autologous bone is recommendable. Bonefill – materials for bone
graft does not substitute and does not have the properties of the autologous
After implanting the biomaterial,
a waiting period of 6 to 9 months should be observed for the dental implant
procedure, or when the implant occurs simultaneously with the graft, the same
waiting period should be observed.
The increase of the ridge of the
material depends on the volume and nutritional power of the receiving site
Despite al the in vivo and in
vitro toxicity and biocompatibility tests not showing secondary responses,
incompatibility reactions to Bonefill – materials for bone graft cannot be
completely excluded. Possible undesirable reactions may occur in the sequence
of any surgery, including edema on the surgical site, haemorrhage, site
inflammation, bone loss, infection or pain.
Pregnancy and Lactation: There is
no data available on the use of the product during pregnancy and lactation. For
safety reasons, pregnant or nursing mothers should not be treated with Bonefill
– materials for bone graft. The safety and efficacy of Bonefill – materials for
bone graft were not investigated in children prior to their skeletal maturity.
The professional should assess
the characteristics of the bone support suitable for implanting since bone
density is a variable and determining factor in the planning and execution of
endosteal implants Each type of density has different advantages and
disadvantages, which will determine the most suitable planning. The bone
density influences the surgical technique and time of healing. Therefore, the
prior knowledge of the bone density becomes an indispensible factor for correct
According to MISCH, C.E (1998),
there are 5 groups of bone density, independent of the region in the dental
arch, based on the macroscopic characteristics of the cortical (external
portion of the bone) and the trabecular bone (internal portion of the bone):
D1 Dense cortical bone;
D2 Has dense cortical and thick trabecular
D3 Thin cortical bone and thin
D4 Thin trabecular bone;
D5 Non-mineralized bone, immature
Depending on the location and
time an area remained edentulous, its density will be variable. However, there
are areas where the types of bones are most commonly found: D1 is found in the
atrophic anterior mandible; D2 is found in the region of the anterior mandible,
posterior mandible and anterior maxilla; D3 is found in the region of the
anterior maxilla, posterior maxilla, posterior mandible and osteoplasty in D2
bone; and D4 is found in the region of the posterior maxilla. Ideally, the
surgeon should establish a post-operative control protocol, including measures taken
during observed situations.
surgeon is also recommended to keep a follow-up report of the evolution of the
case together with the results.
Note: There are no load restrictions for the product.
– materials for bone graft, like all other biomaterials, should not be placed
in existing active infection or in any other degenerative disease that alters
the quality of the material. It should be used with special precaution in
patients with acute or chronic infection in the surgical site (e.g.: cysts,
osteomyelitis, acute necrotizing ulcerative periodontitis, acute sinusitis)
should not be used in patients that, under the clinical point of view, cannot
be subjected to a dental intervention. Such as patients with uncompensated diabetes.
– materials for bone graft is not indicated for pediatric dental patients.
is contraindicated in procedures different from that recommended in the item
Bonefill – materials for bone graft, should not
be exposed to the outside environment.
CONDITIONS FOR THE PRODUCT’S STORAGE AND TRANSPORTATION, CONSERVATION AND/OR
Store and transport away from direct sunlight,
sources of heat (keep at room temperature of 15 - 25°C) and humidity. Keep
the pack sealed until time of use. Ensure the integrity of the pack before use.
Do not use if the sterile pack is open or damaged or has an expired
sterilization date in order to avoid possible contamination. Dispose of the
uncharacterized product according to the effective legislation for hospital
wastes or return the damaged packs and device to the manufacturing plant.
instructions for use in periodontal correction procedures
A basic requirement for a well successful
periodontal treatment includes the control of any bacterial infection as well
as careful oral hygiene. Therefore, it is advisable to have a health promotion
and oral preparation phase prior to the surgical implant procedures, combined
with instructing the patients regarding the oral hygiene maintenance
procedures. Also, carry out a careful treatment of the periodontal lesion
(scraping, root planning, decontamination and debridement) before the implant.
The application of the granulated biomaterial in the bone defects should be
followed by the use of barrier or membrane for good tissue regeneration.