Abstract
Background: This study evaluated the safety and effectiveness of a tissue-engineered skin product composed of viable neonatal keratinocytes and fibroblasts and compared it to a free gingival graft (FGG) in a procedure to enhance keratinized tissue (KT) and wound healing around teeth that do not require root coverage. Methods: Twenty-five subjects were enrolled who had at least two non-adjacent teeth in contralateral quadrants exhibiting an insufficient zone of attached gingiva requiring soft tissue grafting where root coverage was not desired. One tooth was randomized to receive an FGG, and the other was randomized to receive bilayered cell therapy (BCT). The amount of KT was measured at baseline and 3 and 6 months, and the texture and color of the grafted tissue were compared to the surrounding tissue at months 1, 3, and 6. A questionnaire was used to determine subject preference at 6 months. Biopsies and persistence studies were performed on a subset of the subjects. Results: The FGG generated statistically significantly (P