It must be mixed with the B-TCP scaffold particles for at least 10 minutes extra orally before applying it into the patient’s mouth. The PDGF will bind to the graft and will not be lost as shown in the literature. Due to the binding time, it is not recommended for PDGF alone to be applied directly into the mouth.

GEM 21S® is a versatile biologic agent, that aids in both soft tissue and hard tissue healing. GEM 21S® is indicated to treat the following periodontally-related defects:

• lntrabony periodontal defects;
• Furcation periodontal defects; and
• Gingival recession associated with periodontal defects.

In principle, growth factors act better without a membrane (more blood supply). If the defect is contained (3 wall defect), there is no need to apply a membrane since the walls will provide the space to maintain the graft in place with GEM 21S®. However, in the case of a non-contentive defect, the membrane is needed and must be placed.  Without proper stability of the graft, there will not be regeneration.

Currently, there is only a single use kit available, containing one syringe  of 0.5 mL rhPDGF-BB (0.3 mg/mL solution) and 0.5cc of B-TCP [Ca3(PO4)], a highly porous, resorbable osteoconductive scaffold.

The clinician prepares GEM 21S® by fully saturating the B-TCP scaffold particles with the rhPDGF-BB solution and letting the product sit for approximately ten minutes. It is best to prepare GEM 21S® just after the patient isanesthetized, and then place the graft hydrated with GEM after the granulation tissue is properly removed. This willgive plenty of time for the rhPDGF to bind to the graft prior to placement into the defect.

Yes, GEM 21S® is a synthetically made product.

rhPDGF is pure and sterile, so there are no enzymes, or contaminants to degrade it. GEM 21S^® has undergone rigorous stability testing of the product, reviewed by FDA, to ensure it does not degrade over the shelf life of the product.

There is no trace of anything derived from humans in GEM 21^®.