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Frequently Asked Questions (FAQ's) for BioGraft
What is Synthetic Hydroxyapatite ?

Synthetic hydroxyapatite (HA) is a biocompatible, nontoxic, slowly resorbing, osteoconductive, osteophillic material, hydrophilic in nature, and has a high compressive and low tensile and shear strength. It has a close structural and chemical resemblance to bone mineral, but not identical.

 
What are Bioactive Glass Ceramics ?

Bioactive glass ceramics from the SiO2, CaO P2O5 family can develop a chemical bond with  living hard tissues though the development of a surface layer of carbonated hydroxyapatite. When these materials are exposed to tissue fluid, bioactive glasses are covered by silica rich gel  on top of which calcium phosphate rich layer is formed. The calcium phosphate rich layer promotes absorption and concentration of osteoblast cells to form an extra cellular matrix and mineralization.

 

Is Hydroxyapatite Bioactive Glass (HA-BG) Composite Bone Graft materials superior than Bioactive Glass Bone Substitute materials?

HABG Composite Bone Graft materials have an added advantage as they contain HA particles that act as a scaffold, encircling which osteoid could get deposited, resulting in early increase in strength of the newly forming bone. Bioactive glass containing graft particles may have an effective role in the treatment of periapical defects as compared to Hydroxyapatite.

 
Can BioGraft Synthetic Hydroxyapatite material be used for correction of facial skeletal and soft tissue defects ?

Yes. BioGraft Synthetic Hydroxyapatite material has the property of ingrowth of fibrovascular tissue and osteo conductivity and thus can be used for correction of facial skeletal and soft tissue defects. BioGraft Synthetic Hydroxyapatite materials are bio-compatible, non-allegenic, non-toxic and qualitatively superior to the imported Hydroxyapatite.

 
What is the role played by BioGraft Synthetic Hydroxyapatite material in correction of facial skeletal and soft tissue defects?

Due to increased awareness, more and more surgeries for correction of facial abnormalities are being done. In India incidence of live birth with craniofacial clefts alone is in several thousands per year. Patients with facial skeletal and soft tissue defects due to acquired factors are much more. Synthetic Hydroxyapatite Bone Graft material is a useful alternative where the donor area is limited and/or donor area morbidity is unwanted. This material is affordable and within the reach of poor patients also.

 
What are the facial deformities for which BioGraft Synthetic Hydroxyapatite material can be used ?

BioGraft Synthetic Hydroxyapatite material, available both in Granules and Pre-forms, can be used for treatment of following facial deformities.

  • Congenital facial and craniofacial clefts.
  • Hemefacial microsomia
  • Post traumatic facial skeletal defect.
  • Benign facial skeletal neoplasm.
  • Aesthetically unacceptable facial skeletal defect like midface retrussion, microgenia, micrgnathia.
  • Correction of soft tissue defect.
 
What are the diseases for treatment of which BioGraft Synthetic Hydroxyapatite material can be used?
Disease Nature of disease
Cleft lip and palate Congenital
Temporo-mandibular joint ankylosis Post traumatic
Rare craniofacial cleft Congenital
Giant adamantinoma of mandible Neoplastic
Malocclusion of teeth Developmental
Chronic osteomyelitis of mastoid Infective
 
What is the method generally followed for use of BioGraft Synthetic Hydroxyapatite material for correction of facial skeleton deformities?

Operations are performed under general anesthesia. Target bone is exposes property and its surface is made raw with the help of periostium elevator on which BioGraft Synthetic Hydroxyapatite material is applied. After irrigation with normal saline, the soft tissue pocket is closed meticulously. Post operatively the patients are kept under antibiotic coverage for 5 to 7 days. The common complications are hematoma and facial edema which subside during next 5 to 7 days. In some cases, edema last for about 3 weeks. It depends on the amount of soft tissue dissection. Infection may occur at the graft site from time to time, which subside with systemic application of antibiotics and dressing. As the graft becomes vascularised, the infection passes away. Average use of analgesics is much less as there is no donor site morbidity.

 
What is the duration within which new bone form following surgery for correction of facial skeleton deformities?

Post operatively nearly upto 3-4 weeks, grafted site remain tender and there are palpable crepitus. Thereafter, grafted area become firm in consistency and gradually tenderness passes away. At about 6 to 7 months the area becomes hard and clinical evidence of bone formation may be appreciated by radiograph but best by 3D CT.

 
Give details of few surgeries for facial skeletal and soft tissue defects with BioGraft Synthetic Hydroxyapatite materials and result obtained.
Operation Result
Cleft palate + Maxillary hypoplasia
Surgery - Repair of cleft lip + nasal correction. Application of Hap over alveolus + ant surface of maxilla
Bone formation after 6 months
Giant adamantinoma of mandible
Surgery - Subtotal excision of mandible, reconstruction by free fibula + recon plate + Hap Grafting
Uneventful, Solid bone formation after 6m
Secondary cleft lip deformity + maxillary Hypoplasia
Surgery - Correction of lip deformity + application of HA over anterior surface of maxilla and alveolus
Satisfactory bone formation within 7 months.
Primary cleft lip U/L + maxillary hypoplasia
Surgery - Repair of cleft lip + HA application over maxilla
Same
Secondary Cl lip + Palate + Severe Maxillary hypoplasia
Suregry - Correction by pharyngeal flap palatoplasty
Bone formation within 5-6 months

Atypical facial cleft
Surgery - Correction of facial cl + application of HA over anterior surface of Maxilla across the cleft

Early infection, drainage of abscess cured the problem. Bone formation – 9m.
Cleft lip with alveolar gap + Maxillary hypoplasia
Surgery - Correction of cleft lip with application of HA over alveolus + base of ala + ant surface of maxilla
Bone formation – satisfactory
Severe cleft lip + Palate / Wide gap + Severe maxillary collapse
Surgery –Repair of cleft palate by check mucosal flap
Repair of cleft lip
LeForte – advancement osteomy of maxilla + HA graft applied over line of osteotomy/ pterygoid process/ ant. surface of maxilla
Satisfactory
Chronic Mastoiditis, Osteomyelitis of mastoid with cavity
Surgery - Curratage of the cavity, Packing with HA graft, coverage of the wound by rotation flap and skin graft
Bone formation and obliteration of the cavity.
What are the deterrents to placement of dental implants?

Dental implant placement in the posterior maxillary region is frequently hampered by atrophic ridges resulting from bone resorption which could either be following tooth removal or from the effects of periodontal disease. Tooth loss occurring in the maxilla, generally result in bone resorption both apically and palatally. Problem of compromised alveolar ridge may be in addition to maxillary sinus varying in size and shape and thus requiring surgical intervention for implant placement. Unless cavity following tooth extraction is filled in to maintain alveolar ridge, maxillary sinuses pneumatize after tooth loss and expand in such a way thereby compromising or preventing implant placement without an augmentation procedure.

 
What are the common requirements for sinus lift procedure?

Following are the most common requirements for sinus lift procedure.

  • Resorbed alveolar crest under the maxillary sinus must be of a minimum height say about 5mm for placement of implant.
  • Following sinus augmentation procedure, implant may surgically be placed after a minimum healing period of 6 to 12 months varying from patient to patient.
  • Development of maxillary posterior for the atrophic ridge either through sinus graft or ridge augmentation procedure require bone graft material which could either be autugraft, allograft, xenograft or synthetic material and many a times accompanied by the use of GTR membrane.
 
What are the categories of Bone Graft materials ?

Bone Graft materials can be categorized in following four types.

  • Autograft or autogenous bone graft i.e. patients own bone.
  • Allograft or allogenic bone graft i.e. of same species.
  • Xenograft or xenogenic bone graft i.e. of two different species (bone of bovine origin).
  • Alloplast or alloplastic i.e. Synthetically derived, which could either be hydroxyapatite, ß-TCP or any formulation thereof, bone graft.
 
What is the purpose of using Allograft or Xenograft or Alloplast graft materials ?
Generally, main purpose is to avoid a secondary surgery for harvesting autogenous bone.
 
What is the ideal bone graft material ?

Ideal bone graft/replacement material should exhibit four characteristics namely

  • Osteointegsation, the ability to chemically bond to the surface of bone without an intervening layer of fibrous tissue
  • Osteoconduction, the ability to support the growth of bone over its surface
  • Osteoinduction, the ability to induce differentiation of pluripotential stem cells from surrounding tissue to an osteoblastic pleno type and
  • Osteogenesis, the formation of new bone by osteoblastic cells present within the graft material.
 
What are the applications of BioGraft Bone regenerative/substitute materials ?

Some of the applications of BioGraft Bone Regenerative/Substitute materials are the following.

  • For socket preservation following extraction of a tooth or to augment an atrophied or resorbed site.
  • For sinus lifting preceding placement of dental implants.
  • For ridge expansion.
  • For treatment of Periodontitis.
 
What is Periodontitis ?

Periodontitis is a chronic inflammatory disease of the periodontium occurring in response to bacterial plaque on the adjacent teeth, characterized by gingivitis, destruction of alveolar bone and periodontal ligament, apical migration of the epithelial attachment resulting in the formation of periodontal pockets and ultimately loosening and exfoliation of the teeth.

 
What causes Periodontitis ?

Bacteria in our mouth along with mucus and other particles, constantly form a sticky, colorless 'plaque' on teeth. Unless such plaque is removed by brushing and flossing, the same hardens and form bacterial harboring 'tartar'. Plaque and tartar on teeth, cause inflammation of gums called 'gingivitis' and unless treated advance to 'periodontitis'. Factors like Smoking, Diabetes, Stress etc are found to accelerate periodontitis.

 
How does one know that he / she is suffering from periodontal disease ?

Some of the symptoms may be the following:

  • Sensitive teeth.
  • Mobile teeth
  • Pain during chewing
  • Red swollen gums
  • Tender or bleeding gums
  • Bad breath
 
How is Periodontitis generally treated ?

Periodontitis is generally treated either by scaling and root planing or medications or surgery. Type of treatment vary from patient to patient and objective is to control the infection. Surgery include Flap Surgery and Bone Graft Surgery. Grafting in addition to flap surgery, is done to replace or encourage new growth of bone or gum tissue destroyed by periodontitis and BioGraft bone regenerative materials in this regard are useful.

 

Why Synthetic Bone Grafts are preferred for filling bony defects?

Because they have desired consistency, particle size, porosity and strength with availability in abundance in sterile condition. These features totally eliminate donor site morbidity and risk of viral transmission associated with Autogenous grafts and Xenografts respectively.

 
What are the disadvantages of Autogenous Bone Grafts?
Donor site morbidity and limited availability etc
 
What are the disadvantages of Xenografts?
Risks of viral transmission, varied fusion and healing rates.
 
What is the most commonly used Bone Graft material?
Hydroxyapatite is the most commonly used Bone Graft material.
 

What are 'Bio Ceramic' materials?

Ceramics are oldest man made material consisting of non-metallic inorganic substances. Bio Ceramics are those ceramics which are used to repair and reconstruct diseased or damaged parts of the body.

 

What are the types of Bio Ceramics?

Bio Ceramics can be of various types i.e. inert, active and resorbable etc.
 
What are the uses of Calcium Phosphate based Ceramics?

Calcium Phosphate based Ceramics are being used in various disciplines of medicine i.e. Orthopaedics, maxillofacial surgery, spinal surgery, dentistry for augmentation of alveolar ridge etc..

 
Which are the two forms of Calcium Phosphate Ceramics receiving most attention and why ?

Two forms of Calcium Phosphate Ceramics receiving most attention are the following:

  • Synthetic Hydroxyapatite (HA) and
  • Beta Tri-calcium Phosphate (TCP)

This is because these two forms have mineral composition similar to that of natural bone, bio-compatible and bond well with natural bone. Their bio-compatibility makes them successful bone substitutes. These have been found to be safe and effective for a variety of clinical applications.

 
What are Biphasic Calcium Phosphate Ceramic (BCP) material ?

Composition both Synthetic Hydroxyapatite and Beta Tri-calcium Phosphate are called Biphasic Calcium Phosphate Ceramic material.

 
What are the advantages of Biphasic Calcium Phosphate Ceramic (BCP) material?

Studies have shown that BCP has osteo inductive properties. HA implants have successfully been used to prevent post extraction alveolar ridge resorption. BCP has the combined advantages and properties of both HA and TCP.

 
How is Hydroxyapatite different than Beta Tri-Calcium Phosphate ?

HA is the natural mineral component of vertebrate hard tissue, comprising 60-70% of bone and 98% of of dental enamel. HA in appropriate synthetic form is generally found to be bio-active and non-bio-resorbable. HA has osteoconductive potential.

TCP is clinically similar to HA but is not a natural component of bone. It is partially resorbable and is often considered desirable for repair of non-pathological site. This act as temporary space filler or scaffolds for new tissue to develop. Natural tissue reconstruction occurs simultaneously with resorption of the ceramic.

 
What are the advantages of Calcium Phosphate bio materials ?

Calcium phosphate bio-materials are devoid of local or systemic toxicity, do not elicit inflammatory or foreign body response, can become functionally integrated with natural bone with no fibrous tissue encapsulation and cause no alteration of normal bone minerlization process. Also they become bonded to bone by apparently natural bone cementing mechanism.

Calcium phosphate bio-material provide a physical matrix suitable for deposition of new bone and can display growth guiding properties causing bone to extend its growth into areas it would not otherwise occupy. It also has the ability to maintain bone bulk in areas where bone resorption normally takes place.

 
What is BioGraft-HA?
It is a synthetic bone regenerative material made of 100% Pure HA.
 
What is BioGraft-HT?
It is also a synthetic bone regenerative material made by combining 100% Pure HA and TCP in appropriate proportions.
 
What is available Granule size of BioGraft-HA and BioGraft-HT?

BioGraft-HA and BioGraft-HT are available in Granule size range of 0.25 mm (250 microns) to 4 mm (4000 microns). These materials can also be made in other Granule sizes requested for.

 
What’s the shelf life of BioGraft-HA and BioGraft-HT? Are these Sterile products?

These Products are being marketed with Shelf Life of 3 years. Yes, these Products are sterilized by Gamma Ray irradiation.

 
How are BioGraft-HA and BioGraft-HT Granules used?

These Granules are wetted either with patient blood or PRP (Patelet Reinforced Plasma) or saline solution and placed directly on application area in conjunction with Guided Tissue Regeneration Membrane (GTP) and followed by sutures.

 
Are BioGraft-HA and BioGraft-HT also available in pre-formed shapes and sizes?

Yes these materials are available in different pre-formed shapes like square, rectangle, cone, triangle, circular, semi-circular etc in different standard sizes of appropriate porosity. Pre-forms of specific design and sizes can also be made available.

 
Are pre-forms of BioGraft-HA and BioGraft-HT brittle. Can they be cut and shaped?
No. Although these are porous, they can be cut and shaped by careful handling..
 
Is method of use of BioGraft-HA and BioGraft-HT Granules different than that of pre-forms?

No but pre-forms are meant for filling of larger voids.

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