Health TrialsbyHealthPanel

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

ConditionsAcellular Dermal MatrixBone GraftingSoft Tissue Grafting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

At least 18 years old

Must be a patient of the UAB Dental School

Able to read and understand informed consent document

Disqualifiers

Non-English speaking

Less than 18 years old

Smokers/nicotine users (defined as currently reporting use of any form of tobacco/nicotine products)

Uncontrolled diabetes (HbA1c > 7%)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Guided Bone Regeneration with ADM (AlloDerm) as a barrierExperimental treatment 1 intervention
Group B: Guided Bone Regeneration with Resorbable Crosslinked Collagen Matrix (Mem-Lok) as a barrierActive comparator 1 intervention

Trial outcomes

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

Time frame
baseline to 6 months

Secondary outcomes

1

Soft tissue thickness change

Clinical assessment using an endodontic reamer and a calibrated periodontal probe

Time frame
9 months
2

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).

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: