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NCT07613047
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Conditions: Acellular Dermal Matrix, Bone Grafting, Soft Tissue Grafting
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 70
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07613047). StuddyBuddy aggregates publicly available trial information.