유니케어바이오메디칼 제품소개: 싸이토플렉스 차폐막 과 베나셀 지혈거즈

About Us

Unicare Biomedical, Inc.'s mission is to provide scientifically sound and high quality medical products for the healthcare community. The Company focuses on the development and supply of wound care and tissue regeneration products for dental and orthopedic applications. These products facilitate bone regeneration and the management of bleeding as a result of surgical operations or traumatic injuries.

MORE THAN 20 YEARS SERVING THE MEDICAL INDUSTRY

 

1999

Unicare Biomedical became incorporated and entered the growing field of implant dentistry.

 

2000

Sets out manufacture of the first FDA cleared bone grafting material, Unigraft®, for use in the reconstruction of extraction sites and alveolar ridge reconstruction.

 

2001

Introduction of Cytoflex® Tef-Guard®, the novel micro-porous ePTFE barrier membrane for use in guided tissue regeneration procedures. The non-resorbable micro-porous barrier was specifically designed to improve flap attachment while preventing new tissue and bacteria penetration.

 

2002

Cytoflex® Mesh, the golden precision titanium mesh, receives clearance by the FDA for the fixation of bone grafting material. The mesh is less intrusive, easy to trim, and shapes easily into three-dimensional contours for the containment of bone graft material.

 

2008

BenaCel®, a resorbable hemostatic wound dressing is approved for the management of bleeding wounds. Its exceptional hemostatic ability makes it perfect for addressing surgical wounds and traumatic injuries.

 

2009

Further FDA clearance of BenaCel® dental dressing in the management of alveolar osteitis (dry socket) in extraction sites, and for the management of oral surgical wounds, proving the broad applications of BenaCel® hemostatic wound care products.

 

2009

Introduction of Cytoflex® Resorb, a micro-porous, synthetic resorbable membrane for guided tissue regeneration applications. The poly(lactide-co-glycolide) resorbable barrier gradually dissolves over a 90 day period and does not require a second retrieval procedure.

 

2013

Textured Cytoflex® Tefguard®, a textured version of our initial non-resorbable micro-porous barrier, is introduced for GTR/GBR applications. The patent pending textured barrier provides micro and macro texture on both surfaces to enhance flap attachment.

 

2015

Cytoflex® Titanium Mesh is improved upon by increasing the firmness of the material and adding a reinforced edge, while still providing optimal flexibility when shaping for intricate contours. The new M4 model mesh contains pure titanium and a distinct golden color for a more aesthetic compatibility with a patient's gingiva.

 

2016

Introduction of Ti-Enforced™, a Titanium-reinforced, multi-layer, ePTFE membrane, designed for more secure graft containment during wound healing as well as to provide a favorable environment for bone regeneration to the desired contour. The bacteria blocking, Ti-Enforced™ ePTFE membrane has a thin and easily conformable profile facilitating bone regeneration for the most demanding conditions.

 

At Unicare Biomedical bringing the best quality products to the medical community motivates us to continually innovate from within and stay relevant with the healthcare industry. We promise to work with our strategic partners as well to make sure that quality also comes with affordability and a responsibility to our patrons and the care of their patients.

 

BENACEL® DENTAL DRESSING

I was introduced to Benacel at a Dental Hands on Extraction course in Guatemala with Dr. Tommy Murph and Dr. Gayle Fletcher. I was amazed at the ease to place…Benacel has removed almost all dry sockets that I was encountering and the healing time has been reduced.

– Dr. Patrick Liedl, DDS, 2,700+ Benacel plugs/sheets

BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation.

BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.

 

Product Benefits

Completely resorbable within days
Prevents dry socket formation
Non-allergenic, non-pyrogenic and non-immunogenic
Economical and easy to use

 

Benacel® Clinical Studies

• A retrospective study on the use of a dental dressing to reduce dry socket incidence in smokers

 

 Q & A WITH AN EXPERIENCED BENACEL® USER

Dr. Tommy Murph, author of "Extraction Guide for the Exodontist", Hands on Extraction Course Director, Inventor the "Dr. Murph Crane Pick"
Conway, South Carolina

 

1. How long have you been an exodontist?
• 25 years
2. How long have you used BenaCel® Dental dressing? What do you use BenaCel® mostly for?
• Over 7 years
• Prevention of Dry Sockets
3. Prior to BenaCel® Dental Dressing, what products did you use and why did you decide to switch to BenaCel® Dental Dressing?
• Gel-Foam mostly. Benacel is so much easier to use and costs less.
4. There are several configurations of BenaCel®. How do you decide which configuration is preferred for each case?
• Very Simple...Size one is for small conical sockets, Size 2 is for lower molars and buccal roots of upper molars, Size 3 is for Large conical roots and sinus perforations
5. Is BenaCel® easy to use and what is the best way to use it?
• Very Easy too use. Many new BenaCel® users don't put it in deep enough. You have to pack it down into the socket so it doesn't come out
6. How long does it takes for BenaCel® to resorb?
• It varies from 1 to 2 weeks, or more, depending on the amount of BenaCel® used and bleeding conditions.
7. After placing BenaCel® in the socket, do you retain the material with sutures? If so, what sutures do you use and how do you place the sutures to retain BenaCel®?
• Only if there is a sinus perforation to prevent the material from dislodging into the sinus space. Chromic Gut is my suture of choice and I run the suture through the hole in the size 1 and 3 BenaCel® before closing a sinus perforation.
8. Have you used BenaCel® on patients who take blood thinner, such as Aspirin® or Coumadin®?
• BenaCel® is mandatory for any patient on a blood thinner. Just common sense that you want to do everything possible to get a clot and maintain a clot in this patient group.
9. Have you used BenaCel® for any another purpose, other than bleeding and dry socket management?
• I use it mainly for dry socket prevention, but you can use it to TREAT a dry socket that presents to your office by cleaning the socket, packing with BenaCel® and then suturing the socket closed.
10. Have your patients encountered any allergic reactions or complaints due to BenaCel®?
• Never, on the contrary we have had some patients report to us that they had STOPPED smoking and wondered if the material had any chemical composition that would make them not want to smoke. As far as I know it doesn't, but we tell them Congratulations, glad we could help you stop smoking.

 

CYTOFLEX® TI-ENFORCED®

Cytoflex Ti-Enforced is the best PTFE membrane in the market. It has predictable outcomes and has changed my practice.

– Dr. Samuel Lee, 500+ Cytoflex Ti-Enforced membranes

 

Ti-Enforced™ ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced™ membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.

 

 FAQ

1. What is Ti-Enforced™ membrane made of?

Ti-Enforced™ membrane is composed of a titanium frame enclosed within two layers of expanded polytetrafluoroethylene (ePTFE) material. It is a passive, non-load bearing membrane.

 

2. What is the purpose of enclosing a titanium frame within an ePTFE membrane?

The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft migration during wound healing. Ti-Enforced™ membranes are designed to reduce the migration and establishment of gingival tissue derived cells into bony defects thus providing a more favorable environment for neovascularization and bone derived cells to repopulate and repair the defect.

 

3. What is the enclosed titanium frame made of?

The titanium frame is made of pure, implantable grade titanium.

 

4. What are the indications of Ti-Enforced™ membrane?

Ti-Enforced™ membrane is cleared for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle. It is a temporarily, non-resorbable, implantable material.

 

5. How long is Ti-Enforced™ membrane implanted for?

The membrane is intended to be submerged and implanted for more than 30 days and up to 6 months.

 

6. Are Ti-Enforced™ membranes textured on both sides?

All Ti-Enforced™ membranes have micro and macro texture on both surfaces.

 

7. What are the Advantages of Texturing on Both Surfaces?

By having both surfaces of Ti-Enforced™ textured, doctors do not have to be concerned about which side should face up toward the gingival tissue or face down toward the bone graft material. This makes it easier for doctors to use the membrane.

The unique strawberry field texture pattern provides more surface area for the gingival tissue to adhere to the membrane, and to stabilize the wound site. The texture surface facing the bone graft material prevents the membrane from sliding around the graft material, making it easier to position the membrane over the graft material.

 

8. May Ti-Enforced™ be trimmed and shaped to fit a variety of defect sizes?

The membrane may be cut to the desired configuration with scissors. After trimming, there should be no sharp corners or rough edges. To enhance stability and adequate protection of the space over the bony defect, the membrane should be trimmed to extend 3mm beyond the defect margins and to remain at least 1mm from adjacent, uninvolved teeth. The membrane may be curved to create a dome shape, if desired, for containing the graft.

CAUTION: Excessive bending of the titanium frame or trimming of the membrane close to the titanium frame may cause the membrane to delaminate. If the membrane delaminates or if the titanium frame perforates through the ePTFE material, it should not be used. The membrane should be handled using only powder free gloves and/or with sterile atraumatic forceps.

 

9. May screws or tacks be used to stabilize Ti-Enforced™ membranes?

Ti-Enforced™ membranes can be stabilized with surgical tacks or screws.

 

10. What are the recommended closure techniques?

In general, a double layer closure, with a deep layer of horizontal mattress suture followed by a standard wound closure with interrupted suture is recommended. During primary closure, adequate flap release must be accomplished in order to achieve a tension-free closure. The use of long lasting monofilament suture is recommended to prevent premature loss of suture strength, which may lead to early membrane exposure during the initial 2-week healing period.

 

11. How should the membrane be removed?

When removal is desired and the membrane is exposed, the membrane may be removed, by grasping with a forcep and gently remove it from the tissue. Local anesthesia may be provided to enhance patient comfort, but is not necessary. If primary closure is obtained at placement, surgical exposure may be required for removal. Re-epithelialization will occur within 2 to 3 weeks to complete the healing process. After membrane removal, final bone maturation will take place for 6 to 12 months from the time of implantation. This time frame should be considered in treatment planning cases involving prosthetic loading of regenerated bone.

 

12. Can unused portions of Ti-Enforced™ membrane be re-sterilized and re-used?

No, Ti-Enforced® membranes are designed for single use only.

 

13. What is the shelf life of Ti- Enforced™ membranes?

Ti-Enforced™ membranes are double packed and have a 4-year shelf life from date of manufacture.

 

14. Have you ever confirmed an allergic reaction to Ti-Enforced™ membranes?

There has been no reported allergic reaction caused by Ti-Enforced® membrane. It is made of inert, biocompatible ePTFE material.

 

15. Are there any contraindications?

Ti-Enforced™ membranes are not designed for use under load bearing conditions.

 

16. What are the potential complications?

Possible complications associated with any oral surgery include infection, flap slough, perforation, abscess formation, bone loss, pain and complications associated with the use of anesthesia. Depending upon the type and severity of the complication, as judged by the clinician, early material removal may be required.

 

CYTOFLEX® MESH

Cytoflex® Mesh is made of a pure, implantable Titanium mesh with precision mesh profile. This product is designed for use to ensure three-dimensional reconstruction of alveolar bone defects and to facilitate bone augmentation through adequate fixation of the augmentation material. The thin, supple mesh conforms easily to tissue contours, and yet presents sufficient stiffness to maintain a space over the bony defect.

 

Cytoflex Mesh® Clinical Studies

• Regeneration of Multiple Adjacent Bone Dehiscences with Guided Tissue Regeneration After Orthodontic Proclination: A Corrective Treatment Approach

 

 FAQ

1. What are the advantages of Cytoflex Mesh?

Cytoflex Mesh was designed for ease of use to securely contain the bone graft material in a 3-dimensional curve. It can be easily trimmed with surgical scissors, draped over the defect contours and prevent spontaneous collapse after primary closure.

2. Will Cytoflex Mesh tear during screw fixation?

Cytoflex Mesh is made with pure titanium with a precision mesh profile. It is made with sufficient strength to prevent tear during a normal screw fixation procedure.

3. What bone screw sizes are suitable for Cytoflex Mesh?

The most common size screw used with Cytoflex Titanium Mesh is the 4mm size. Really any size from 3mm ¡V 5mm screws will be suitable depending on the clinical situation (i.e. thickness of bone and where the mesh is placed) but the 4mm size is more commonly used.

4. What makes the Cytoflex Mesh a golden color?

All Cytoflex Titanium Mesh goes through an anodizing process to strengthen the metal and leaves it with a golden hue.

5. Can M4-300 model be fixated with an abutment screw?

The M4-300 model was designed for fixation with an abutment screw. The fixation hole has a diameter of 2.5mm, suitable for fixation with most abutment screws.

 

CYTOFLEX® SMOOTH TEF-GUARD®

I generally achieve good bone regeneration after 4-5 months of healing…I like the ease of use and would recommend Tef-Guard® products for socket grafting.

– Dr. David Kao, DDS, 600+ Tefguard membranes

 

Cytoflex Smooth Tefguard is a non-resorbable, space-making, barrier membrane intended for guided tissue regeneration procedures. Composed of proprietary micro-porous polytetrafluoethylene (ePTFE) thin film, Cytoflex smooth Tefguard has a surface texture and porosity suitable for host cells to attach upon. The micro porous surface is designed to prevent bacteria from penetrating through the membrane while promoting diffusion of interstitial fluid for optimal healing. It also allows for improved adhesion between gingiva tissue and the membrane, preventing passage and integration of bacteria within the interstices of the material.

The supple membrane conforms easily to tissue contours and offers sufficient rigidity to maintain space over the bony defect. The smooth version has micro pore texture on both surfaces. The cellular micro texture is invisible to the naked eye but can be seen at high magnifications.

 

 Q & A WITH AN EXPERIENCED TEFGUARD® USER

Dr. David Kao, Periodontics and Dental Implants

Fullerton, CA

1. How long have you used non-resorbable Cytoflex® Tef-Guard® products? What do you use the products mostly for?

I have used the products since 2011. Mostly I used them for socket grafting with the non-primary closure technique.

2. Do you notice any differences between smooth versus textured Cytoflex® Tef-Guard® products?

For the way I use Tef-Guard® in my office, I have not noticed little clinical differences in the smooth and textured. The handling property of the textured membrane is a bit improved over the smooth version. I find that the textured membrane is more durable. This does allow it to withstand the pressures tucking the membrane in below the gingiva. I also find that I can trim it better, but only marginally better. I will continue to use smooth only for its cost savings.

3. In your experience, what is the best way to use the product? Do you under-fill the bone graft or fill to the crest level of the bone before applying the membrane? What suturing technique do you use over the membrane? What kind of sutures do you use to close the wound?

In my experience, the best way to use the product is to stabilize the membrane by extending about 3 mm between the bone and the labial and lingual flaps. If the interdental papillae were not elevated, then a suture would not be necessary. If a suture were necessary, I would utilize a mattress suture over the membrane (either cris-cross or parallel). I commonly use a resorbable suture, such as chromic gut. I have tried both under-filling and over-filling. With the over-fill technique, it is common to experience non-integrated bone graft at the crest. I am inclined to say that under-filling works well.

I generally achieve good bone regeneration after 4-5 months of healing with just an allogenic bone graft (FDBA), Tef-Guard® membrane without primary closure in an intact tooth socket or a socket with minimal bone loss.

4. How long do you leave the membrane in place?

I try to leave the membrane in place for 4 weeks. After four weeks, you would get a moderately mature connective tissue with a few spicules of bone graft integrated in it. However, all cases end up with fully mature gingiva. After the removal of the membrane, the patient is advised to resume normal activity. No painkiller or dressings are needed.

5. What is the best way to remove the membrane? What instruments do you use?

I remove it by first lifting the membrane with a periodontal probe and extract it with cotton forceps.

6. Have you experienced any wound dehiscence while using this membrane? If so, what do you think caused the dehiscence? Any thoughts to prevent such complications?

I have not experienced wound dehiscence with the non-primary closure technique. In general, wound dehiscence is caused by injury (either during or after the procedure), poor blood supply, or thin tissue.

7. Do you find Cytoflex® Tef-Guard® easy to use?

I do like the ease of use and would recommend Tef-Guard® products for socket grafting without primary closure.

 

 FAQ

1. How is this membrane different from Gore-Tex® and Cytoplast® membranes?

Micro porous Cytoflex® Tefguard® was designed to improve upon experiences learned from Gore-Tex® and Cytoplast® membranes. Macro porous Gore-Tex® was the gold standard of barrier membranes for use under primary soft tissue coverage. The macro pores were designed for tissue ingrowths to stabilize tissue/barrier interface. However, membrane removal after bone regeneration is traumatic. The featureless Cytoplast® membrane was designed to block off soft tissue and bacteria ingrowths, allowing the barrier to be used in non-primary coverage conditions. The relatively non-porous nature of the barrier limits nutrient permeation across the membrane. Cytoflex® Tefguard's® proprietary micro pores were designed to allow nutrient permeation and at the same time prevent penetration of soft tissue and bacteria across the membrane. The combination of nutrient diffusion and micro porous texture enhances soft tissue attachment while preventing bacteria penetration across the membrane.

2. What about primary soft tissue coverage of the membrane?

Cytoflex® Tefguard® membranes were designed to serve as a barrier to contain the bone graft material and prevent soft tissue and bacteria in-growth. At the discretion of the practitioners, the barriers have been used in primary coverage and non-primary coverage situation when soft tissue coverage is lacking. The membrane was designed to block off bacteria and thus exposure of the membrane does not result in infection and case failure.

3. How long can the membrane stay in place?

In general within four to five weeks the membrane will need to be removed. This will allow enough time for the osseous tissue to begin forming and to be able to resist soft tissue from invading the graft site. However, at the discretion of the clinician, primary closure and longer healing times may be considered, if desirable.

4. How to remove the membranes?

Under primary coverage condition, Cytoflex® Tefguard® membrane may be easily removed by creating a small incision in its proximity. With forceps, firmly grasp a border of the material and remove it from the tissue. Local anesthesia is normally used for this procedure. In non-primary coverage situation, the membrane may be lifted with a periodontal probe and extracted with a forcep. After membrane removal, re-epithelialization will occur within two to three weeks to complete the healing process. Final bone maturation will take place for six to twelve months from the time of implantation. This time frame should be considered in treatment planning cases involving heavy prosthetic loading of regenerated bone.

5. What is the difference between the Smooth and Textured Cytoflex® Tefguard® barrier membranes? What are the benefits of each as opposed to the other?

Both Cytoflex® Tefguard® membranes have micro-texture. The micro texture allows for better soft tissue attachment over the membrane and a better seal around the bone graft area. The Textured Cytoflex membranes also provide a visible macro-texture similar to the configuration of strawberry fields as opposed to the conventional pot-hole design of other barrier products. This strawberry field texture was designed to further enhance soft tissue attachment and minimize dehiscence over the grafting site.

6. Can unused portions of the membrane be resterilized?

No, Cytoflex® Tefguard® membranes are designed for a single use only.

7. What is the shelf life the Cytoflex® Tefguard® membranes?

Each sterile Cytoflex® Tefguard® barrier is double packed and has 6-year of shelf life from the date of manufacture.

8. Have you ever had a confirmed allergic reaction to micro porous Cytoflex® Tefguard® membranes?

Cytoflex® Tefguard® membranes are made of inert and biocompatible PTFE materials. Since it was cleared in 2002, there have not been any reported allergic reactions caused by Cytoflex® Tefguard® PTFE barrier.

9. Are there any contraindications?

Cytoflex® Tefguard® membrane is a passive, non-load bearing material and should not be used for load bearing applications. Cytoflex® Tefguard® should not be considered for patients where general oral surgery is not advisable.

10. What are the potential complications?

Possible complications associated with any oral surgery include infection, flap slough, perforation, abscess formation, bone loss, pain and complications associated with the use of anesthesia. Depending upon the type and severity of the complication, as judged by the clinician, early material removal may be required.

www.ossco.kr

TEL 02 779 2880~1