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

NCT07613047 | Not Yet Recruiting

• 2 other identifiers: IRB-300016808UAB Periodontology
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator-initiated study will compare ADM and resorbable cross-linked collagen membrane barriers for guided bone regeneration at atrophic lateral ridge augmentation sites.

Conditions

Soft Tissue Grafting; Acellular Dermal Matrix; Bone Grafting

Keywords

soft tissue graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Soft tissue thickness change

  9 months

• Patient centered outcomes using the Visual Analog Scale (VAS)

  4 weeks

Study Arms (2)

Guided Bone Regeneration with ADM (AlloDerm) as a barrier

EXPERIMENTAL

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

Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier

ACTIVE COMPARATOR

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

Interventions

Guided Bone Regeneration with ADM (AlloDerm) as a barrier PROCEDURE

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.

Guided Bone Regeneration with ADM (AlloDerm) as a barrier

Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier PROCEDURE

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.

Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrier

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Alloderm

Study Officials

• Maria L Geisinger, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Geisinger, DDS, MS

CONTACT

205-934-4984; miagdds@uab.edu

Sarah Startley, DMD

CONTACT

205-975-8711; ss1971@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)