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
Study type: Interventional
Phase: Phase 2

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
    

Detailed description: 
      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. The
      hypotheses for the study is that the use of ACM in preservation of bone dimensions in
      extraction socket will result in greater remaining horizontal and vertical ridge dimension,
      and reduced postoperative discomfort when compared with D-PTFE in sites where extraction
      socket will not be closed by advancing the gums. Subjects in need of single rooted teeth
      extraction on both left and right side of the same jaw will be recruited. Pre-surgical
      clinical and radiological measurements will be made using dental calipers, stents and reduced
      cone beam computed tomography (CBCT) three dimensional scans. Involved teeth will be
      extracted with minimal trauma. Freeze dried bone allograft (bone from human donors) will be
      used in all extraction sockets. ACM will be used in the one extraction socket and D-PTFE in
      the other extraction socket without advancing the gums to cover the socket. A Visual Analog
      Score (VAS), pain scale questionnaire will be given to record the postoperative discomfort
      and patient will be seen for routine post-operative monitoring as well as research
      measurements. At 3-months recall postoperatively, clinical measurements and radiographic
      measurements will be recorded as before. Wound fluid will also be collected at all visits.
      The sites will be reentered and trephine core (bone sample) will be collected for
      histomorphometric as well as microtomographic assessment. Statistical analysis will be
      performed to test the significance using a mixed-model analysis of variance (ANOVA).
    

Intervention name(s): Placing Amnion chorion membrane over grafted site; Placing d-PTFE membrane over grafted site
Intervention type(s): Device; Device
Intervention description(s): 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
Other intervention name(s): BioXclude; Cytoplast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alveolar Ridge Augmentation; Tooth Socket; Guided Tissue Regeneration; Membranes