Recruiting

ADM vs. Collagen

Sponsor:

University of Alabama at Birmingham

Code:

NCT07613047

Conditions

Acellular Dermal Matrix

Bone Grafting

Soft Tissue Grafting

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Guided Bone Regeneration with ADM (AlloDerm) as a barrier

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

Study Details

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

Acellular Dermal Matrix

Bone Grafting

Soft Tissue Grafting

Study ID

NCT07613047

Start date

Sep 10, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 and Locations

Central contacts

Maria Geisinger, DDS, MS

205-934-4984miagdds@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Maria Geisinger, DDS, MS

205-934-4984miagdds@uab.edu

Sarah Startley, DMD

205-975-8711ss1971@uab.edu

Principal Investigator:

Maria Geisinger, DDS, MS

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • soft tissue graft

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.