Prospective, Assessment of Alveolar Ridge Preservation Using Biotivity™ Amnion Chorion Membranein Atraumatic Extraction Socket
University of Maryland, Baltimore
Summary
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.
Description
This randomized, controlled, parallel-arm clinical study investigates the use of Biotivity™ A/C Plus Membrane, a bioactive human amnion chorion-derived barrier membrane, in alveolar ridge preservation (ARP) of Type I or II extraction sockets. Subjects will be randomized to receive either the investigational amnion chorion membrane or a conventional collagen membrane (CopiOs Extend) over cancellous allograft (Puros®) after flapless tooth extraction in the premolar or molar region (excluding third molars). The study will evaluate: Primary outcome: soft tissue wound healing over 5 months using…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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. Acti…
Interventions
- DeviceAmnion chorion membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
- DeviceCollagen membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..
Location
- University of Maryland School of DentistryBaltimore, Maryland