Living cellular constructs for keratinized tissue augmentation: A 13-year follow-up from a split-mouth randomized, controlled, clinical trial.

Abstract

to evaluate the long term outcomes of living cellular construct (LCC) compared to free gingival graft (FGG) for keratinized tissue width (KTW) augmentation in the natural dentition. Twenty-four subjects out of the original 29 enrolled participants were available at the 13-year follow-up. The primary endpoint was the number of sites demonstrating stable clinical outcomes from 6 months to 13 years (defined as KTW gain, stability or ≤ 0.5 mm of KTW loss, together with reduction, stability or increase of PD and REC ≤ 0.5 mm). Secondary outcomes included the assessment of KTW, attached gingiva width (AGW), recession depth (REC), clinical attachment level (CAL), esthetics and patient-reported outcomes (PROMs) at the 13-year visit, assessing the changes from baseline to 6 months. Nine sites per group (42.9%) were found to have maintained stable (≤ 0.5 mm or improved) clinical outcomes from 6 months to 13 years. No significant differences were observed for the clinical parameters between LCC and FGG from 6 months to 13 years. However, the longitudinal mixed model analysis showed that FGG delivered significantly better clinical outcomes over 13 years (p<0.01). LCC-treated sites exhibited superior esthetic outcomes compared to FGG-treated sites at 6 months and 13 years (p<0.01). Patient-esthetics was significantly higher for LCC over FGG (p<0.01). Patient overall treatment preference was also in favor of LCC (p<0.01). A similar stability of the treatment outcomes from 6 months to 13 years was found for LCC- and FGG-treated sites, with both approaches shown to be effective in augmenting KTW and AGW. However, superior clinical outcomes were found for FGG over 13 years, while LCC was associated with better esthetics and patient-reported outcomes than FGG. This article is protected by copyright. All rights reserved.