Clinical Trial: Ridge Preservation Comparing the Healing With or Without a Barrier Membrane

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Brief Summary: Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Detailed Summary: Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Sponsor: University of Louisville

Current Primary Outcome: Change in post-extraction site to 4 month change in crestal osseous width [ Time Frame: 4 months ]

Changes in post-extraction to 4 month change in ridge measurements at the mid defect alveolar crest and 5 mm apical taken with a caliper.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Soft tissue thickness [ Time Frame: 4 months ]
    Soft tissue thickness measurements taken with a #40 endodontic reamer.
  • Percent osseous tissue [ Time Frame: 4 months ]
    A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.


Original Secondary Outcome: Same as current

Information By: University of Louisville

Dates:
Date Received: June 9, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: June 9, 2016
Last Verified: June 2016