• Frequently Asked Questions

 

GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System

 

General Product Information

1. What is the material composition of GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System?
A: GUIDOR easy-graft is a two-part synthetic system comprised of beta-tricalcium phosphate (β-TCP) granules coated with a polylactide polymer (PLGA) along with a liquid activator (BioLinker®) comprised of N-methyl-2-pyrrolidone (NMP). GUIDOR easy-graft does not contain any substances of animal or human origin.

2. Is GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System radiopaque?
A: Yes. GUIDOR easy-graft appears opaque on x-rays.

3. What is the composition of the BioLinker® activator? What is BioLinker made of?
A: BioLinker activator contains N-methyl-2-pyrrolidone (NMP). NMP is widely used in the pharmaceutical industry in subcutaneous drug release systems and in the medical device industry in dental membranes.

4. Where is GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System manufactured?
A: GUIDOR easy-graft is manufactured in Switzerland by a fully-owned subsidiary of Sunstar, Degradable Solutions AG.

5. What literature exists for GUIDOR easy-graft CLASSIC Alloplastic Bone Graft System?
A: For a complete list of clinical reports, please go to Scientific Publications for GUIDOR easy-graft

 

Packaging & Storage

1. How is the GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System packaged?
A: GUIDOR easy-graft is available in Large, Medium, and Small. Regardless of product size, each unit of GUIDOR easy-graft contains three foil packs with one syringe of granules and one ampule of 0.42 mL BioLinker®. See table below for granule net volume by product size.

Product Size #Granule Net VolumeGranule Size
GUIDOR easy-graft Large 0.40 ml 500-1000µm
GUIDOR easy-graft Medium 0.25 ml 500-1000µm
GUIDOR easy-graft Small 0.15ml 500-630µm

The foil pouch is sterilized using a gamma sterilization process and placed in an exterior box (i.e. carton) with the instructions for use (IFU) and doctor’s patient tracking labels. A Technique Guide for Minimally Invasive Ridge Preservation is included in the shipping package.

2. How should GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System be stored?
A: Product should be stored in its original packaging at temperatures from 41° to 77° F (5° to 25° C). Keep away from sunlight.  Do not freeze.

 

When to Use – Indications, Precautions & Warnings

1. For what procedures can GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System be used?
A: GUIDOR easy-graft is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillofacial indications may include:

  • Extraction defects (alveolar ridge preservation)
  • Periodontal defects
  • Peri-implant defects
  • Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR)
  • Sinus floor augmentation
  • Defects after surgical extractions
  • Defects after removal of bone cysts
  • Defects after root resection of apicoectomy
  • Defects after removal of autologous bone

2. Are there any contraindications for GUIDOR® easy-graft®?
A: GUIDOR easy-graft should not be used in pregnant or nursing women. Bone grafting should not be considered for patients where general oral surgery is contraindicated. GUIDOR easy-graft use should be avoided in cases where there is uncontrolled disease or therapies which are detrimental to the healing of bone, such as acute or chronic infection (osteomyelitis) in or around the surgical site, severe metabolic diseases, such as uncontrolled or poorly controlled diabetes mellitus, hyperparathyroidism, or osteomalacia, osteoporosis, high dose therapy with corticosteroid, and severe renal dysfunction, severe liver disease. Refer to Instructions for Use (IFU) for additional Precautions and Warnings.

3. Can GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System be used without a suture and/or membrane?
A: The use of a membrane or suture is left to the discretion of the practitioner. Do not leave the defect open for the following indications: periodontal defects, filling of peri-implant defects; augmentation of alveolar crest (e.g. Guided Bone Regeneration, GBR), sinus floor augmentation, defects after surgical removal of retained teeth, defects after removal of bone cysts, defects after root end resection, and defects after removal of autologous bone.

 

How to Use – Preparation

1. Is a radiograph necessary?
A: Yes. Radiographic evaluation of the defect site is essential to assess the extent of the defect for surgical planning. The radiograph and clinical examination can be used to estimate the amount of GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System required prior to the surgical intervention.

2. Can GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System be mixed with autogenous bone or bone graft substitutes in the application syringe?
A: No. Mixing GUIDOR easy-graft with autogenous bone chips or foreign materials will change the setting characteristics of GUIDOR easy-graft and may cause the material to harden prematurely in the syringe or prevent the material from hardening in the defect.

 

How to Use - Placement Procedure

1. Can I prepare GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System in advance of the planned bone graft case?
A: No. GUIDOR easy-graft should be opened and prepared just prior to use.

2. Should defects be overfilled?
A: No. The site should not be overfilled as the GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System swells approximately 10% after application. The bone graft should be firmly compressed into the extraction site with injection and compression repeated as needed until the height of the alveolar bone is reached.

3. Will compression cause granule breakage?
A: No. The round granules of GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System withstand compression and will not fracture.

4. When is the use of dental membrane recommended with GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System?
A: The decision to use a dental membrane is left to the discretion of the practitioner. GUIDOR easy-graft is stable in defect and may not require a dental membrane for containment in 3 or 4 walled defects. Flat (non-concave defects with limited walls) defects or defects of a critical size may require the additional support of a dental membrane. Sites where a full thickness periosteal relieving flap is created may also benefit from a dental membrane for exclusion of soft tissue ingress.

5. When can an implant be placed after using GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System to fill the extraction socket?
A: Regeneration of bone depends on the anatomical and physiological conditions at the extraction site and treatment philosophy of the practitioner.

6. Can an implant be placed immediately after filling a defect with GUIDOR® easy-graft® CLASSIC Alloplastic Bone Graft System?
A: Implant placement immediately after filling a defect with GUIDOR easy-graft is not recommended. The bone grafting material is not intended for immediate load-bearing. Implants must be anchored in local bone with primary stability.

 

How to Use – Healing Process

1. How long does it take for the GUIDOR® easy-graft® CLASSIC Alloplastic Bone Grafting System to resorb?
A: GUIDOR easy-graft is designed to offer complete resorption via physiological dissolution and cell based mechanisms in 5-15 months which is dependent on multiple biological and medical factors. GUIDOR easy-graft resorption takes place in parallel to bone regeneration.

2. What will I see during re-entry?
A: Upon re-entry, granules may be seen in the soft tissue because of their distinct white color.