Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix

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 cross-linked collagen membrane barriers for guided bone regeneration at atrophic lateral ridge augmentation sites.

Study Overview

• Status: Not yet recruiting
• Conditions: Acellular Dermal Matrix; Bone Grafting; Soft Tissue Grafting
• Intervention / Treatment: Procedure: Guided Bone Regeneration with ADM (AlloDerm) as a barrier; Procedure: Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu
• Study Contact Backup: Name: Maria Geisinger, DDS, MS; Phone Number: 205-934-4984; Email: miagdds@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Sarah Startley, DMD; Phone Number: 205-975-8711; Email: ss1971@uab.edu
      • Contact: Maria Geisinger, DDS, MS; Phone Number: 205-934-4984; Email: miagdds@uab.edu
      • Principal Investigator: Maria Geisinger, DDS, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking
• At least 18 years old
• Must be a patient of the UAB Dental School
• Able to read and understand informed consent document
• Patients presenting with a diagnosed need horizontal ridge augmentation with GBR without simultaneous implant placement, to allow for future dental implant placement.
• Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of the edentulous span planned for GBR, or unhealthy adjacent teeth to be extracted during the same visit.
• ≤4 mm ridge width in a Seibert Class I Edentulous span19
• No anticipated need for surgical and/or endodontic care at planned teeth adjacent to the proposed surgical site during the study period.

Exclusion Criteria:

• Non-English speaking
• Less than 18 years old
• Smokers/nicotine users (defined as currently reporting use of any form of tobacco/nicotine products)

• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing, including:

  • Uncontrolled diabetes (HbA1c > 7%)
  • Untreated periodontal disease
  • History of head/neck radiation
  • IV bisphosphonates
  • Immunocompromised state
  • Pregnancy
  • Acute infection at site
• Documented or suspected allergy or sensitivity to any study product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Bone Regeneration with ADM (AlloDerm) as a barrier; GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. Following decortication and graft placement to reconstruct the horizontal ridge deficiency, acellular dermal matrix (ADM) will be adapted to fully cover the augmented site with appropriate extension beyond the defect margins. The ADM will be stabilized using titanium tacks and/or periosteal sutures as needed to ensure space maintenance and membrane stability.	Procedure: Guided Bone Regeneration with ADM (AlloDerm) as a barrier; GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. Following decortication and graft placement to reconstruct the horizontal ridge deficiency, acellular dermal matrix (ADM) will be adapted to fully cover the augmented site with appropriate extension beyond the defect margins. The ADM will be stabilized using titanium tacks and/or periosteal sutures as needed to ensure space maintenance and membrane stability.
Active Comparator: Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier; GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. The graft will be contoured to reconstruct the horizontal ridge deficiency following decortication of the recipient site. A resorbable collagen membrane [Mem-Lok® Resorbable Collagen Matrix (RCM) will be trimmed and positioned to fully cover the grafted area with extension beyond the defect margins and stabilized using titanium tacks and/or periosteal sutures as needed.	Procedure: Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier; GBR will be performed using a composite particulate graft consisting of a combination of freeze-dried bone allograft (FDBA) and xenograft in a 75%/25% mixture. The graft will be contoured to reconstruct the horizontal ridge deficiency following decortication of the recipient site. A resorbable collagen membrane [Mem-Lok® Resorbable Collagen Matrix (RCM) will be trimmed and positioned to fully cover the grafted area with extension beyond the defect margins and stabilized using titanium tacks and/or periosteal sutures as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horizontal ridge width gain	Horizontal ridge width gain (mm) at 6 months post-GBR (CBCT-based measurement) at 2mm and 4mm from the alveolar crest	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue thickness change	Clinical assessment using an endodontic reamer and a calibrated periodontal probe	9 months
Patient centered outcomes using the Visual Analog Scale (VAS)	Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 2 weeks and 4 weeks postoperatively, using the Visual Analog Scale (VAS) This measurement ranges from 0-10 (0 being better and 10 being worse).	4 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Maria L Geisinger, DDS, MS, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: soft tissue graft
• Additional Relevant MeSH Terms: Alloderm
• Other Study ID Numbers: IRB-300016808; UAB Periodontology (Other Identifier: University of Alabama at Birmingham)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from this study will not be shared with other researchers outside of our research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No