- What is Cytoflex® Resorb membrane made of?
Cytoflex® Resorb membrane is made of biodegradable polyglycolide, polylactide and lactide/glycolide copolymers. These polymers are biocompatible and used in many implant devices, including resorbable sutures and bone fixation screws. Cytoflex® Resorb breaks down first by hydrolysis, then by metabolic processes, eventually turning into water and carbon dioxide.
- What are the indications of Cytoflex® Resorb?
Cytoflex® Resorb was cleared by the FDA for use as a space making barrier in the treatment of periodontal defects, including two or three wall bony defects, class II furcations, recession type defects, circumferential defects, and dehiscence defects associated with dental implants.
- How long can Cytoflex® Resorb membrane be implanted for?
Cytoflex® Resorb membrane has a barrier function of about 2 months and is completely resorbed by the body within 6 months.
- Which side of Cytoflex® Resorb should face the gingival tissue?
The membranes are asymmetric and must be placed with the correct surface facing outward. The surface with the distinct diamond pattern embossing (large grating) should face the gingival tissue. The smoother surface should face the bony defect or bone graft site. NOTE: In the inner package, the embossed layer faces the dentist.
- Can Cytoflex® Resorb be trimmed to fit a variety of defect sizes?
Yes, the membrane may be cut to the desired configuration with scissors. To enhance stability and adequate protection of the space over the bony defect, the membrane should be trimmed to extend 2-3mm beyond the defect margins and at least 1 mm away from adjacent, uninvolved teeth.
- Is soaking required prior to administration?
Cytoflex® Resorb can be administered without pre-soaking. The membrane absorbs little water and body fluids and maintains its stiffness when wet or after implantation.
- 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. Closure should be maintained for at least two weeks after surgery. The use of a 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.
- Does the Cytoflex Resorb require primary closure? Can it be left exposed?
Cytoflex Resorb membranes must be implanted under primary closure and should not be left exposed after implantation.
- Can unused portions of Cytoflex® Resorb membrane be re-sterilized and re-used?
No, Cytoflex® Resorb membranes are designed for single use only.
- What is the shelf life of Cytoflex® Resorb membranes?
Cytoflex® Resorb has a shelf life of 3-years from the date of manufacture.
- Have you ever had a confirmed allergic reaction to Cytoflex® Resorb membranes?
There have been no reported allergic reactions caused by Cytoflex® Resorb membranes.
- Are there any contraindications to the use of Cytoflex® Resorb?
Cytoflex® Resorb membrane should not be used for load bearing applications or for patients where general oral surgery is contraindicated. Patients with the following defects cannot expect optimal wound healing with GTR surgery.
- Extremely severe defects with little or no periodontium.
- Defects that preclude making adequate spaces such as horizontal defects.
- Flap perforations or compromised flap preparations that have previously occurred during surgery.
- Multiple tooth procedures in which more than two pieces of Cytoflex® Resorb membranes are implanted next to each other.
- WARNING: No clinical data on treating the following patients with Cytoflex® Resorb has been collected (Consult with the patient's physician prior to treatment):
Pregnant women, patients with an artificial heart valve or any other artificial prosthetic devices, immuno-compromised patients (diabetes, chemotherapy, irradiation and HIV infection), and patients with a history of connective tissue disease or steroid use either at the time of treatment or for one year period prior to treatment.
- CAUTION: Cytoflex® Resorb membranes maintain their stiffness after wetting. After trimming, there should be no sharp corners or rough edges in order to prevent tissue irritation and/or protrusion. The membranes must be implanted under tension free primary closure.
It is not advised to use this membrane in patients with a thin biotype or insufficientsoft tissue to achieve primary closure.
Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.