All components/accessories are supplied sterile for single use only. The external surface of the rhPDGF-BB syringe and β-TCP cup are not sterile. Therefore, care must be taken to ensure that these components are handled in such a way that sterility is maintained in the surgical field. The GEM 21S® kit and its components must not be resterilized.
GEM 21S® is supplied as a single use kit. Any remaining product must be discarded and not reused. Post-operative patient management should follow the same regimen as similar cases utilizing autongenous bone grafting. Pre-requisites for all regenerative procedures include prevention of wound dehiscence, a stable clot, and minimal bacterial contamination.
Directions for Use
Aseptic Technique and Preparing GEM 21S®
Treating an Intrabony Defect with GEM 21S®
Treating a Gingival Recession Defect with GEM 21S®Aseptic Technique and Preparing GEM 21S®
Familiarization with the device, proper sterile surgical grafting techniques, and thorough debridement of the bony defect are extremely important when using GEM 21S®. Following are instructions for preparing GEM 21S®. [ View video ]
View the Package Insert:
United States Canada - English Canada - FrenchTo view a presentation about GEM 21S®, click here.
Following exposure of the defect, with a full thickness mucoperiosteal flap, all granulation tissue must be carefully removed. Thorough soft tissue debridement of the defect is critical to successful regeneration. Granulation tissue, if left in the defect, could be stimulated by the rhPDGF-BB component, diminishing the desired regenerative response. Exposed tooth root surfaces should also be thoroughly planed.
Following thorough debridement of the osseous defect, the clinician, based on his or her experience, estimates the amount of GEM 21S® needed to fill the defect. For best results, GEM 21S® must completely fill the defect to the level of the surrounding bony walls. Overfilling should be avoided. Prepare the GEM 21S® graft by fully saturating the β-TCP particles with the rhPDGF-BB solution and letting the product sit for approximately ten (10) minutes.
The saturated GEM 21S® should be placed into the defect using moderate pressure, taking care not to crush the particles. In order to enhance the formation of new bone, GEM 21S® should be placed in direct contact with well-vascularized bone. Excessive bleeding should be controlled prior to placing grafting materials. Following placement of the GEM 21S® and completion of any additional surgical steps, the mucoperiosteal flaps should be sutured to achieve primary closure wherever possible. [ View video ]
[ BACK TO TOP ]
Treating a Gingival Recession Defect
Treating gingival recession defect, especially in the esthetic zone, remains an important and challenging surgical procedure. The primary objectives when treating gingival recession are to improve esthetics, prevent further gingival recession and to decrease root sensitivity. An additional goal when using GEM 21S® is to help promote the regeneration of lost periodontal tissues. In treating recession defects with GEM 21S®, the need for a remote donor site is eliminated.
Following adequate preparation and removal of the smear layer of the exposed root, use a #15C scalpel blade to begin to develop bilateral divergent, full-thickness releasing incisions by beginning in the vestibular mucosa, moving toward the papillary region. Avoid involving the free gingival margin on the adjacent teeth. Next, make a careful intrasulcular incision in order to facilitate the reflection of a full-thickness mucoperiosteal flap. Using a periosteal elevator, carefully reflect a full-thickness mucoperiosteal flap to just beyond the mucogingival junction. Using a wider, regular #15 scalpel blade, create a partial-thickness flap apically. Bluntly dissect into the vestibular lining mucosa in order to allow passive coronal advanced of the flap. Apply PDGF solution to the exposed root surface.
Saturate a small amount of β-TCP with the PDGF solution for approximately 10 minutes. Carefully place a small amount of the saturated β-TCP over the denuded root surface. Only a very thin layer of the prepared matrix particles should be placed over the root surface. In placing the saturated bone matrix particles, it is extremely important to place the material no closer than 3 mm to the CEJ.
Next, cut to size an absorbable collagen wound healing dressing (i.e.) CollaTape) and saturate the dressing with the PDGF solution. Place the saturated collagen dressing over the entire grafted area. Using resorbable sutures in each papillary region, suture in place the resorbable collagen dressing. The purpose of placing the collagen dressing is to help contain the GEM 21S® graft in its proper position on the root surface and add additional space between the underlying grafted site and the overlying coronally advanced flap. Retention of such space is necessary to help promote regeneration of cementum, periodontal ligament, and supporting alveolar bone.
Without tension, coronally advance the prepared mucoperiosteal flap to the level of the CEJ. Place resorbable sutures at each papilla area to initially stabilize the flap in its properly advanced position. Finally, suture each vertical releasing incision with multiple resorbable sutures.