Clinical Trial: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Brief Summary: Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Detailed Summary: Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. 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 19, 2015
Date Started: August 2015
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016