Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
Condition: Alveolar Bone Loss; Pathological Conditions, Anatomical
MeSH terms: Alveolar Bone Loss; Pathological Conditions, Anatomical
Intervention: Placing Amnion chorion membrane over grafted site; Placing d-PTFE membrane over grafted site
Intervention description: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed; Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alveolar Ridge Augmentation; Tooth Socket; Guided Tissue Regeneration; Membranes

Summary:

      The purpose of this study is to examine if a biologically active commercially available
      amnion chorion membrane (ACM) is as effective as the commercially available inert dense
      polytetrafluoroethylene membrane (D-PTFE) in preserving jaw bone dimensions and whether it
      provides the added benefit of reducing post-operative discomfort after dental surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects needing bilateral non-molar dental extractions in the same arch and
             consenting to a 2nd surgery for core-biopsy participated in the study. Subjects were
             required to be within the American Academy of Anesthesiologists (ASA) classifications
             ASA I or ASA II. Males between 18-75 years and females between 18-50 years of age were
             screened.

        Exclusion Criteria:

          -  inability or anticipated failure to maintain adequate oral hygiene; evidence of active
             periodontitis; pregnant or breastfeeding mothers, unstable systemic diseases or with
             compromised immune system (e.g., uncontrolled diabetes, etc.) or unstable bleeding
             disorders; active infectious diseases (e.g., hepatitis, tuberculosis, HIV, etc.);
             mental disabilities that may hinder participation; active immunosuppressive therapy,
             cancer therapy and/or radiation to the oral cavity within last 6-months;
             conditions/medications contraindicated for bone regeneration (e.g., methotrexate,
             steroids, bisphosphonates, cyclosporin-A), and and self-reported tobacco usage
             (equivalent to >20 cigarettes per day).