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

Abstract

Background: A 13-year follow-up was conducted of a short-term investigation of the use of living cellular construct (LCC) versus free gingival graft (FGG) for keratinized tissue width (KTW) augmentation in natural dentition, to evaluate the long-term outcomes and assess the changes occurring since the end of the original 6-month study.

Methods: 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 probing depth, and recession depth [REC] ≤0.5 mm). Secondary outcomes included the assessment of KTW, attached gingiva width (AGW), REC, clinical attachment level, esthetics, and patient-reported outcomes at the 13-year visit, assessing the changes from baseline to 6 months.

Results: 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-evaluated esthetics were significantly higher for LCC over FGG (p < 0.01). Patient overall treatment preference was also in favor of LCC (p < 0.01).

Conclusions: 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.

Keywords: free gingival graft; gingival recession; living cells; randomized clinical trial; tissue engineering.