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

NCT07613047 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-01

No results posted yet for this study

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

  • Acellular Dermal Matrix
  • Bone Grafting
  • Soft Tissue Grafting

Interventions

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.

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Maria L Geisinger, DDS, MS · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07613047 on ClinicalTrials.gov