Use of microsurfaced acellular dermal matrix for the generation of site-appropriate keratinized tissue in soft tissue augmentation healing: Proof of concept.

Abstract

Background: Autogenous grafts remain the gold standard for soft tissue augmentation, but allogeneic dermal matrices (ADMs) offer a viable alternative. Limited cellular infiltration and neovascularization restrict ADM efficacy; this study investigates a novel microsurfaced ADM (MS-ADM) designed to address these limitations.

Methods: This 180-day, randomized controlled trial evaluated the efficacy of MS-ADM grafts compared to nonmodified ADM in soft tissue augmentation for keratinized tissue generation. Ten patients (seven female, three male; mean age: 54.2 ± 10 years) with ≤1 mm of keratinized tissue were enrolled in a within-subject, examiner-blind trial. Each participant received paired MS-ADM and unmodified ADM (non-MS ADM) grafts at two sites. Healing was assessed via masked clinical photographs (Day 7/14), gingival inflammation scores, and histological biopsies at Day 90. Categorical endpoints were analyzed using McNemar's χ² test for matched data. Outcomes included keratinized tissue width (KTW), recession, probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and patient ratings of discomfort and were analyzed using repeated measures mixed-effects linear regression.

Results: Evaluators consistently rated MS-ADM sites as exhibiting superior healing quality compared to non-MS ADM (p < 0.0001), significantly lower graft displacement (0% vs. 20%), and swelling (0% vs. 20%). Gingival inflammation scores were reduced earlier with MS-ADM, and texture matched surrounding tissue more rapidly. Both graft types generated ≥1 mm of keratinized tissue and clinically relevant KTW ≥2 mm by Day 180. Histology confirmed organized, vascularized mucogingival tissue in both groups but noted reduced inflammatory infiltrate with MS-ADM (n = 8).

Conclusion: MS-ADM demonstrates superior early healing characteristics and reduced complications compared to non-MS ADM, suggesting it to be a superior alternative to conventional, unmodified ADM for soft tissue augmentation. However, the study's small sample size limits generalizability; larger and longer term trials are needed to confirm long-term efficacy and tissue thickness outcomes for soft tissue augmentation.

Key points: Microsurfaced allogeneic dermal matrix (MS-ADM) demonstrated superior early healing quality and faster achievement of normal tissue texture compared to unmodified ADM. Both MS-ADM and non-MS ADM effectively generated clinically relevant keratinized tissue and improved key clinical parameters over 180 days. MS-ADM showed fewer complications, including graft displacement and swelling, suggesting enhanced biointegration compared to non-MS ADM.

Plain language summary: A novel acellular dermal matrix patterned with microsurfaced partial-thickness cuts (MS-ADM) was developed to expand the host-graft interface surface area compared to unmodified ADM, ultimately yielding enhanced biointegration, accelerated cellular adherence and vascularization, shortened graft susceptibility, and improved procedural reliability.