• Frequently Asked Questions

GUIDOR® Bioresorbable Matrix Barrier

 

General Product Information

1. What is the material composition of GUIDOR® Bioresorbable Matrix Barrier?
A: GUIDOR Matrix Barrier is made from a homogenous blend of two polymers, Poly-D, L-lactide and Poly-L-lactide, blended with Acetyl tri-n-butyl Citrate NF (ATBC). These compounds have a history of more than 20 years of use in the food and medical industries.

2. What is the material composition of the ligatures on the GTR membranes?
A: The ligatures on the GTR configurations of the GUIDOR® Bioresorbable Matrix Barrier are made of glycolide/lactide copolymer.

3. Where is GUIDOR® Bioresorbable Matrix Barrier manufactured?
A: GUIDOR Matrix Barrier is manufactured by Sunstar Americas, Inc. near Chicago, Illinois.

4. What clinical data supports the use of the GUIDOR® Matrix Barrier?
A: The safety and efficacy of the GUIDOR Matrix Barrier is well documented in over 100 scientific studies and thousands of successful cases. One recent study includes Dr. Paul Rosen's Purposeful Exposure of a Polylactic Acid Barrier to Achieve Socket Preservation for Placement of Dental Implants in January 2013 Compendium, a good reference when primary closure cannot be achieved. For a complete list of clinical reports, please go to Scientific Publications for GUIDOR Matrix Barrier

 

Packaging & Storage

1. How is the GUIDOR® Bioresorbable Matrix Barrier packaged?
A: Each unit of GUIDOR Matrix Barrier contains one dental membrane. The matrix barrier is placed in a plastic case for protection. The plastic case is placed in a foil pouch and then sterilized using an e-beam sterilization process. The sterilized foil pouch is placed in an exterior box (i.e. carton) with the instructions for use (IFU) and doctor’s patient tracking labels.

2. How should GUIDOR® Bioresorbable Matrix Barrier be stored?
A: The dental membranes should be stored in the refrigerator, at temperatures from 36° to 46° F (2° to 8° C). When using a small refrigerator, do not store GUIDOR Matrix Barrier on the top shelf near the freezer compartment.

 

When to Use – Indications, Precautions & Warnings

1. For what procedures can GUIDOR® Bioresorbable Matrix Barrier be used?
A: The indications of the GUIDOR Matrix Barrier are dependent on the configuration used.

For the GBR configurations: The GUIDOR Matrix Barrier is indicated to aid in bone regeneration and augmentation in oral surgery for extraction socket site preservation, immediate implant placement at time of extraction or delayed placement when additional bone regeneration is desired, ridge augmentation, sinus elevation, and stable barrier for the containment of bone grafting materials.

For the GTR configurations: The GUIDOR Matrix Barrier is indicated for the surgical treatment of periodontal defects, to aid in the regeneration and integration of periodontal tissue components. GTR configurations can also be used as an adjunct in periodontal surgical treatment to supplement the reparative process following scaling and root planing for: Class II furcations, intrabony defects, and recession type defects.

2. Are there any contraindications for GUIDOR® Bioresorbable Matrix Barrier?
A: All configurations are contraindicated in situations where general oral surgery should not be performed, when there is a known sensitivity to material composition of GUIDOR Matrix Barrier and/or there is active or latent infection at or around the surgical site. Refer to Instructions for Use (IFU) for additional Precautions and Warnings.

3. Can I use GUIDOR® Bioresorbable Matrix Barrier without bone grafting material?
A: The use of bone grafting material is at the discretion of the practitioner based on the defect morphology.

 

How to Use – Placement Procedure

1. How long can I leave the GUIDOR® Bioresorbable Matrix Barrier at room temperature?
A: You can prep cases up to 12 hours prior to surgery by placing GUIDOR Matrix Barrier at room temperature. Do not open the foil pouch until immediately prior to the procedure to ensure sterility of the product. Assuming the Matrix Barrier’s foil pouch is not opened and the product has not been out of the refrigerator for more than 12 hours, we advise placing the product back in the refrigerator for future use1.

2. How long does it take to warm GUIDOR® Bioresorbable Matrix Barrier to room temperature (68 - 77⁰ F or 20 - 25⁰ C)?
A: Once removed from the exterior carton, the GUIDOR Matrix Barrier will reach room temperature (68 - 77⁰ F or 20 - 25⁰ C) in the foil pouch after 15 minutes. As part of prep, you can remove the plastic case containing the dental membrane from the foil pouch; GUIDOR Matrix Barrier will reach room temperature in the plastic case (outside the foil pouch) after 1 minute.

3. Can I trim the GUIDOR® Bioresorbable Matrix Barrier?
A: Yes. GUIDOR Matrix Barrier can be trimmed as long as the dental membrane is at room temperature (68 - 77⁰ F or 20 - 25⁰ C).

4. Should I hydrate the GUIDOR® Bioresorbable Matrix Barrier before placing the membrane in the defect?
A: No. There is no requirement to hydrate GUIDOR Matrix Barrier.

5. When placing the GUIDOR® Bioresorbable Matrix Barrier over a defect, how much overlay with the surrounding bone is recommended to ensure the membrane securely tucks under a flap?
A: GUIDOR Matrix Barrier should extend 3 – 4 mm beyond the margins of the defect site for secure placement over the defect and tuck into the flap.

6. Can I tack or suture through the GUIDOR® Bioresorbable Matrix Barrier to secure placement?
A: GUIDOR Matrix Barrier was not designed for use with tacks and does not require sutures through the membrane for secure placement.

7. Should a periodontal/surgical dressing be used?
A: No. Use of a surgical dressing is not recommended because of the risk that it could extend below the gingival margin, into the GUIDOR Matrix Barrier, or into the defect.

8. Can the GUIDOR® Bioresorbable Matrix Barrier be left exposed?
A: In cases where primary closure is not achievable, the GUIDOR Matrix Barrier may be left exposed provided the membrane is securely tucked under the flap and sutures are placed over it. Following exposure, the GUIDOR Matrix Barrier tends to resorb more quickly (approximately 4 weeks) than if fully submerged.

 

How to Use – Healing Process

1. How long does it take for the GUIDOR® Bioresorbable Matrix Barrier to resorb? The ligature?
A: The GUIDOR Matrix Barrier is designed to maintain a barrier function for a minimum of 6 weeks. Resorption of the membrane begins in approximately 3 months with resorption complete in 6 – 12 months, depending on patient situation. The ligatures resorb after 6 months.

2. What should I do if GUIDOR® Bioresorbable Matrix Barrier becomes exposed during the healing process?
A: It is advised to not trim or remove an exposed GUIDOR Matrix Barrier unless it is necessary to relieve patient discomfort. The exposed membrane will disappear due to its combined resorption and attrition. Following exposure, the GUIDOR Matrix Barrier tends to resorb more quickly (approximately 4 weeks) than if fully submerged. To minimize the risk of bacterial infection, application of an antimicrobial agent, preferably alcohol free, such as chlorhexidine is recommended until the dental membrane is no longer present. Topical use of an antimicrobial agent may cause discoloration (darkening) of the Matrix Barrier. Additionally, to avoid premature degradation of the GUIDOR Matrix Barrier, the patient should refrain from mechanical cleaning techniques and chewing at or close to the treated area2.

3. What should I do if an exposed GUIDOR® Bioresorbable Matrix Barrier crumbles/folds/wrinkles on itself during the healing process?
A: Nothing. The characteristic of the GUIDOR Matrix Barrier folding or wrinkling on itself during the healing process when exposed is a documented occurrence. This healing characteristic does not impact a successful outcome. Please refer to Dr. Paul Rosen article in January 2013 Compendium

 

1. Source: Data on File
2. Source: GDR14009 GBR IFU, GDR14010 GTR IFU