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Cytoflex® Tefguard® is a non-resorbable expanded PTFE material membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene ePTFE) thin film, Cytoflex® Tefguard® has a surface texture and porosity suitable for adhesion of host cells to the material while preventing passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect.
Cytoflex Textured Tefguard BenefitsThe textured version of Cytoflex® Tefguard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
Cytoflex ® Tefguard ® - Clinical Case Review
This is a 38 year-old female who presented with a crown-root fracture of the mandibular first molar and a thin gingival biotype. An immediate implant placement following tooth extraction was planned. A flapless, minimally invasive extraction and implant placement combined with guided tissue regeneration was employed to minimize soft and hard tissue recession.
The tooth root was extracted with an intrasucular incision and a periosteal elevator. The extraction socket was curetted to remove all soft tissue remnants. After an implant was placed into the extraction site, the gap between the implant and the socket wall was filled with bone graft particles (Figures 1 & 2). A Tefguard® ePTFE membrane was trimmed to extend 3 mm beyond the socket walls and then tucked subperiosteally under the lingual flap, the buccal flap and underneath the interdental papilla using a curette.
The membrane was allowed to rest passively over the socket (Figure 3), and was stabilized with a criss-cross absorbable PGA monofilament suture without primary closure (Figure 4). After one-week post operation, the graft site was uneventful, and the suture was removed (Figure 5). At three-week post-operation, the soft tissue overlying the exposed membrane demonstrated healing without signs of inflammation. An inadvertent fold in the membrane (introduced during membrane placement) was found at the distal buccal corner (Figure 6).
The decision was made to remove the membrane early to prevent potential complications as a result of the folding of the membrane. After applying topical anesthetic, the membrane was easily removed by grasping with a tissue forcep. A dense, vascular connective tissue matrix was found underlying the membrane in the extraction socket upon membrane removal. Figure 7 shows the site at one week after membrane removal.
Following membrane removal, keratinized gingiva began to form over the grafted socket. At six-week post-operation, the soft tissue was stable with preserved interproximal papillae and natural mucogingival architecture (Figure 8). This case demonstrates the use of a less invasive grafting technique using a micro porous ePTFE barrier.
|Questions and Answers|
There are three significant advantages for having the texture on both sides of the ePTFE Membrane:
Cytoflex Tefguard PTFE membranes are substantially similar to other PTFE membranes on the market. A key diffence though, is that Cytoflex Tefguard PTFE Membrane is made from a microporous expanded PTFE material. This means that it has been stretched on a microscopic level. This improves nutrient permeation across the membrane for healthy bone regeneration. Dense PTFE membranes do not allow nutrient permeation as well as microporous expanded PTFE membranes, like the Cytoflex Tefguard, do.
Micro porous Cytoflex® Tef-Guard® e-PTFE membranes were designed to improve upon experiences learned from the Gore-Tex® and Cytoplast TM 1membranes.
Macro porous Gore-Tex® e-PTFE 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 and primary closure is needed.
The featureless Cytoplast TM membrane is a high density-PTFE (d-PTFE) membrane. d-PTFE, is manufactured specifically to eliminate expansion, and greatly reduce pores, resulting in a material with a submicron (0.2 μm) pore size. Because of this tiny pore size, bacterial infiltration into the site is eliminated with d-PTFE. d-PTFE was designed to block off soft tissue and bacteria ingrowths, allowing the barrier to be used in non-primary coverage conditions. The non-porous nature of the barrier limits nutrient permeation across the membrane. Furthermore, due to its surface, attachment to tissues with d-PTFE is weak, and thus removal of the d-PTFE membranes is a bit easier when compared to Gore-Tex® e-PTFE membranes.
Cytoflex® Tef- Guard®’s is a microporous ePTFE membrane. The membrane was developed with proprietary micro pores that 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 the micro porous texture enhances soft tissue attachment while preventing dehiscence occurrence. Furthermore, soft tissue in-growth is not significant enough with CytoFlex e-PTFE membranes, and so the material is easily retrieved. Finally, at the discretion of the practitioners, the Cytoflex® Tef- Guard®’s micro-ePTFE membranes 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.
1. Cytoplast TM is a registered trademark of OsteoGenics Biomedical, Inc.
Cytoflex® Tef-Guard® 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.
In general within three to four 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.
Under primary coverage condition, Cytoflex® Tef-Guard® 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 removed by grasping with forceps and removing it with a gentle tug. 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.
Both Cytoflex® Tef-Guard® membranes, Textured and Smooth are composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film. It has a surface texture and porosity suitable for adhesion of host cells to the material while preventing passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth.
The Textured Cytoflex membranes provide a visible macro-texture similar to the configuration of strawberry fields as opposed to the conventional pot-hole design of other barrier products. Due to this macro-texture, the handling property of the textured membrane is a bit improved over the smooth version. In addition, some clinicians find that the textured membrane is more durable and that it is easier to trim. The properties of the textured membrane allow it to withstand the pressures tucking the membrane in below the gingiva. The texture was designed to further enhance soft tissue attachment and minimize dehiscence over the grafting site.
No, Cytoflex® Tef-Guard® membranes are designed for a single use only.
Each sterile Cytoflex® Tef-Guard® barrier is double packed and has 6-year of shelf life from the date of manufacture.
Cytoflex® Tef-Guard® 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® Tef-Guard® PTFE barrier.
Cytoflex® Tef-Guard® membrane is a passive, non-load bearing material and should not be used for load bearing applications. Cytoflex® Tef-Guard® should not be considered for patients where general oral surgery is not advisable.
The Cytoflex Textured Tef-Guard PTFE membrane has the same textured surface on both sides of the membrane. It does not matter which side faces the tissue.
The thickness of this membrane is approximately 0.25mm.
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