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

Conditions

• Acellular Dermal Matrix
• Bone Grafting
• Soft Tissue Grafting

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

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 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.

Study Details

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

Key Dates

Start date

Oct 31, 2026

Status verified

May 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Horizontal ridge width gain [ Time Frame: baseline to 6 months ]

Central Contacts

• Maria Geisinger, DDS, MS
  205-934-4984
  [email protected]
• Sarah Startley, DMD
  205-975-8711
  [email protected]

Locations (1)

Find similar trials in Birmingham, AL

Related Studies

• Assessment of Two Soft Tissue Augmentation Using Acellular Dermis Around Dental Implants
  Not Yet Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
  Not Yet Recruiting · Ohio State University · Columbus, Ohio