A Prospective, Double-Arm, Randomized Controlled Trial Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix Compared to Resorbable Collagen Membranes in Edentulous Ridge Augmentation

This investigator-initiated study will compare ADM and resorbable collagen membrane barrier for guided bone regeneration. Systematic reviews and randomized clinical trials confirm that resorbable collagen membranes combined with particulate graft materials predictably increase horizontal ridge width, typically achieving gains of approximately 3-5 mm at 6 months. The biologic mechanism involves clot stabilization, space maintenance (often supported with fixation tacks or tenting screws), and exclusion of competing soft tissue cells. Despite these predictable outcomes, collagen membranes possess inherent limitations, including limited intrinsic structural rigidity, susceptibility to enzymatic degradation when exposed and lack of contribution to gingival phenotype modification.

In contrast, human data evaluating acellular dermal matrix (ADM) as a barrier membrane in horizontal guided bone regeneration is limited. One of the earliest clinical and histologic investigations evaluated ADM in the management of Seibert Class I horizontal ridge defects using particulate grafting and reported both clinical ridge width improvement and histologic evidence of new vital bone formation. Notably, the authors also observed increased soft tissue thickness at treated sites, suggesting a potential dual hard- and soft-tissue benefit for its use. However, this study was a single-arm design without a direct comparator group, limiting the ability to determine whether outcomes were equivalent or superior to those achieved with conventional collagen membranes.

The majority of human ADM literature focuses on periodontal plastic surgery applications rather than GBR, including tooth root coverage procedures to treat gingival recession, peri-implant soft tissue augmentation, and keratinized tissue (KT) augmentation techniques. These investigations consistently demonstrate increased mucosal thickness and KT width with ADM use, reinforcing its soft tissue regenerative capacity. Nevertheless, these outcomes cannot be extrapolated directly to horizontal ridge augmentation without controlled comparative data.

Preclinical animal studies provide additional biologic rationale. It has been demonstrated in a canine GBR model that ADM functioned as an effective barrier membrane, with histologic evidence of new bone formation comparable to bioabsorbable membranes. Additional animal studies have shown that ADM supports vascular infiltration, integrates into host tissues, and maintains an acceptable inflammatory profile during early healing. Histomorphometric analyses in these models report woven bone formation beneath ADM at early intervals, followed by progressive remodeling into lamellar bone. While these findings support the biologic plausibility of ADM as a GBR membrane, animal data cannot substitute for controlled human clinical trials. Importantly, no adequately powered human randomized controlled trial has directly compared ADM and resorbable cross-linked collagen membranes head-to-head in horizontal ridge augmentation with GBR using standardized volumetric CBCT analysis, histomorphometric evaluation of post-healing bone biopsy, and longitudinal soft tissue assessment. Existing studies either evaluate collagen membranes alone, assess ADM in non-comparative design, or evaluate ADM and other autogenous, xenogeneic, or allogeneic soft tissue grafts for phenotype modification without simultaneous GBR. Consequently, it remains unclear whether ADM provides equivalent bone volume augmentation, histologic bone formation, and if it confers additional soft tissue benefits in the context of ridge augmentation, or whether its clinical performance differs in the setting of membrane exposure.

This absence of direct comparative human data represents a critical gap in the literature and provides the rationale for a randomized controlled trial evaluating ADM versus resorbable collagen membranes in horizontal guided bone regeneration.