Clinical Trial: Guided Bone Regeneration Around Immediate Implants

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

Official Title: The Effectiveness of the Cytoplast Technique in Preventing Bone Loss Around Immediate Implant Placement in the Esthetic Zone. A Randomized Clinical Trial.

Brief Summary: An important result of healing after tooth extraction is a reduction in dimensions of the remaining bone at that site. This reduction of bone volume precludes successful restoration of the space using a dental implant. Bone augmentation has shown promise in clinical reports to reduce this loss of bone volume, thus allowing implant placement and restoration. The purpose of this study is to evaluate the clinical and radiographic outcomes of guided bone regeneration around dental implants placed in fresh extraction sockets.

Detailed Summary:

Aim: The purpose of this clinical study is to investigate the effect of a non-resorbable polytetrafluoroethylene (PTFE) membrane on immediate implant placement in the esthetic zone.

Material and Methods: Systemically healthy subjects presenting with a hopeless tooth in the maxillary premolar or anterior region will be recruited in the study. Following a minimally traumatic tooth extraction, subjects will be randomly distributed into one of two treatment groups, a Membrane (Test) or a No Membrane (Control) group. Both groups will receive immediate placement of an implant along with placement of a bone graft material to fill the spaces around the implant. Sites in the test group will receive a non-resorbable PTFE membrane over the socket, whereas those in the control group will receive a collagen dressing over the socket. At sites in the test group, the membrane will be removed at 4 weeks. A second stage surgery and placement of a provisional restoration will be carried out 4 months after implant placement. Final restorations will be placed 3 months after placement of the provisional restoration. Clinical and radiographic measurements will be performed at baseline, implant placement, placement of provisional and final restorations and at the 5-month recall visit.


Sponsor: University of Michigan

Current Primary Outcome: Change in Thickness of Buccal Bone [ Time Frame: One year ]

Change of buccal bone volume over study duration


Original Primary Outcome: Change in bucco-lingual bone width between two time points. [ Time Frame: Baseline, 40 wks ]

Current Secondary Outcome:

  • Change in Interproximal Bone Levels [ Time Frame: One year ]
    Change of interproximal marginal bone loss (mean of mesial and distal sites)
  • Pink Esthetic Score [ Time Frame: One year ]
    Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.


Original Secondary Outcome: Change in crestal bone loss between two time points. [ Time Frame: Baseline, 40 wks ]

as measured on PA radiographs


Information By: University of Michigan

Dates:
Date Received: June 11, 2012
Date Started: July 2012
Date Completion:
Last Updated: February 10, 2017
Last Verified: February 2017