Evaluation Of Trilayer Electrospun Membrane For Keratinized Mucosa Augmentation

This randomized controlled trial aimed to evaluate the 3-year clinical efficacy of electrospun sandwich-structured augmented gingival matrix (AGM) versus free gingival graft (FGG) for keratinized mucosa augmentation around natural teeth. Twenty-eight participants enrolled were randomly divided into AGM and FGG groups (1:1; ChiCTR2000034683). Clinical evaluations were conducted preoperatively (baseline) and at multiple postoperative intervals (2-week, 1-month, 3-month, 6-month and 3-year; between 2021 and 2024) to assess keratinized mucosa width (KMW) as the primary outcome. Secondary evaluations included periodontal parameters (modified plaque index [mPLI], probing depth [PD], and bleeding index [BI]), operation time, patient-reported outcomes and professional aesthetic assessments. Both FGG and AGM significantly increased KMW at 6 months (FGG:3.96 ± 1.33mm; AGM:2.43 ± 0.94mm; p=0.01) and maintained gains at 3 years (FGG:4.25 ± 1.78mm; AGM:2.08 ± 1.51mm; p=0.01), with FGG showing greater augmentation. No significant differences were observed in periodontal parameters or patient-reported outcomes. However, AGM demonstrated superior 3-year aesthetics (color/contour, p<0.01) and 34% shorter operative time (39.50 ± 16.60min vs 59.92 ± 11.55min; p<0.01) versus FGG. AGM effectively increased KMW with stable outcomes maintained for at least 3 years, though slightly less pronounced than FGG. Notably, the application of AGM reduced surgical time and improved aesthetic outcomes, demonstrating its clinical value as a viable soft tissue substitute biomaterial.