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FDA Approves Cell Product for Dental Tissue Regeneration

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The Food and Drug Administration has approved the product Gintuit for regenerating oral soft tissue, made by Organogenesis Inc. in Canton, Massachusetts. The product combines skin cells and connective tissue with bovine collagen and proteins to regrow soft tissue in the mouth resulting from gingival recession, or receding gums.

Gingival recession occurs when the gingiva — the thick tissue that hugs the teeth — moves away from the crown of the tooth. The receding gingiva exposes the tooth’s root, leading to sensitivity and potentially root cavities. One treatment is a soft tissue graft, where a piece of tissue from the roof of the mouth is grafted to the site of the recession. Organogenesis developed Gintuit as an alternative to these grafts.

Gintuit is a cellular sheet that forms a scaffold for gum tissue to regrow and replace the gingiva lost due to gingival recession and produce cell signaling proteins that encourages soft tissue growth. FDA says Gintuit was tested at two clinical trials in adults with insufficient gingival tissue. In each of the two studies, Gintuit was associated with an increase of at least 2 millimeters of gingival tissue in at least 50 percent of study subjects.

The company reports that the new gum tissue better matched the color and texture of the patient’s surrounding tissue than palate grafts. The findings also showed patients prefer Gintuit to grafting procedures, the company adds, when taking into consideration all aspects of treatment: surgery, recovery, and appearance.

Organogenesis says FDA’s decision represents the first approval of an allogeneic — genetically similar but not identical — cell product by the agency’s Center for Biologics Evaluation and Research. It is also the first cell-based technology approved for the dental market, says the company.

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