RECRUITING Phase 4 ClinicalTrials.gov

Biotivity A-C Membrane Socket Preservation Study

Sponsor: University of Maryland, Baltimore • ClinicalTrials.gov ID: NCT07091448

Registry updated: 2026-10-09

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Description

This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement. Throughout the approximately 6-month study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material and barrier placement, and dental implant placement. Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.

Interventions

Amnion chorion membrane (Device)
Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
Collagen membrane (Device)
Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..

Eligibility criteria

Inclusion criteria: 1. Provision of informed consent 2. At least 18 years old 3. In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant 4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan 5. At least one retained natural tooth adjacent to the study site Exclusion criteria 1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis 2. Previous interventions performed involving soft and/or bone grafting in the study site 3. Active caries 4. Uncontrolled periodontal disease present 5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site 6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment 7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day 8. Self-reported use of smokeless tobacco or e-cigarette 9. Self-reported history of current alcohol or drug abuse 10. Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c \> 8.0 within last six-month13,14 11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration 12. Pregnancy, as confirmed by a urine pregnancy test at screening.

Conditions

Alveolar Ridge Preservation

Locations

University of Maryland School of Dentistry — Baltimore, Maryland, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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