Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to
      examine histologic wound healing following ridge preservation using bone allograft that has
      been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire
      protocol involves procedures that are standard care. All materials are FDA-approved materials
      being used in an FDA-approved manner. The test group subjects will have extraction sockets
      grafted with a cancellous non-freeze-dried bone allograft (called PUROS graft). This test
      group will be compared to an active control group using cancellous freeze-dried bone
      allograft (called FDBA). The null hypothesis is that there will be no significant difference
      in formation of new vital bone between treatment groups (primary outcome).

      Each subject will provide a single non-molar tooth site for study treatment. After tooth
      extraction, the graft material will be placed and covered by a resorbable collagen membrane.
      Following 3 months of healing, the dental implant will be place, at which time a core of bone
      will be removed from the site as part of the preparation for the implant. The core biopsy
      will then be evaluated for the primary histologic outcome of % vital bone formation and
      secondary histologic outcome of % residual graft material.
    

Detailed description: 
      The study is designed to examine histologic wound healing following ridge preservation using
      cancellous bone allograft that has been prepared either by freeze-drying (FDBA) or by a
      solvent-based processing method (PUROS). This entire protocol involves procedures that are
      standard care. All materials are FDA-approved materials being used in an FDA-approved manner.
      The test group subjects will have extraction sockets grafted with a cancellous
      non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an
      active control group using cancellous freeze-dried bone allograft (called FDBA). The null
      hypothesis is that there will be no significant difference in formation of new vital bone
      between treatment groups (primary outcome).

      Each subject will provide a single non-molar tooth site for study treatment. After tooth
      extraction, the graft material will be placed and covered by a resorbable collagen membrane.
      Following 3 months of healing, the dental implant will be place, at which time a core of bone
      will be removed from the site as part of the preparation for the implant. The core biopsy
      will then be evaluated for the primary histologic outcome of % vital bone formation and
      secondary histologic outcome of % residual graft material.
    

Intervention name(s): PUROS (Ridge Preservation bone grafting surgery); FDBA (Ridge Preservation bone grafting surgery)
Intervention type(s): Device; Device
Intervention description(s): Ridge preservation bone grafting after tooth extraction; Ridge preservation bone grafting after tooth extraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment