Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to
      examine histologic wound healing following ridge preservation using bovine xenograft and
      porcine xenograft materials.This 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 porcine xenograft (Zcore). This test group
      will be compared to an active control group using bovine xenograft (Bio-Oss). The null
      hypothesis is that there will be no significant difference in formation of new vital bone
      between treatment groups (primary outcome).

      Each subjects will have a non-molar tooth extracted and the socket grafted with either test
      or control graft material. At the time of dental implant placement 18-20 weeks after tooth
      extraction a small core biopsy specimen will be removed from the implant site. 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
      bovine xenograft and porcine xenograft materials.

      This entire protocol involves procedures that are standard care. The study is a 2-arm,
      parallel-design, randomized, prospective clinical trial. The test group subjects will have
      extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared
      to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that
      there will be no significant difference in formation of new vital bone between treatment
      groups (primary outcome).

      In keeping with the protocol our study group has used several times before, the plan will be
      to extract non-molar teeth and graft with the test/control materials. Each subject will
      provide a single non-molar tooth site for study treatment. The graft material will be covered
      with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles,
      Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the
      4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To
      place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is
      placed. This osteotomy can be prepared with either a solid drill, in which case the bone that
      is removed is suctioned into the suction system, or with a hollow trephine drill into which a
      core of bone can be collected. The only "research procedure" being done in the current study
      is the collection of this bone core biopsy for histologic evaluation. 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): Porcine Xenograft (Zcore); Bovine Xenograft (Bio-Oss)
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