Clinical Trial: Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants

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

Official Title: A 3 Arm Controlled Randomised Study: Comparison of Early and Late Loading Protocols in Full Arch Reconstructions in the Edentulous Maxilla, Using The Cresco Prosthetic Sys

Brief Summary: Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants. The study hypothesis is that there is no difference between the bone loss (or gain) between the groups.

Detailed Summary: The study is a controlled randomised study whereby each patient will receive 5-6 implants placed in the edentulous upper jaw supporting a 10-12 unit screw-retained fixed partial denture (FPD). The main objective of the study is to evaluate the performance of Straumann implants supporting a FPD using Straumann Implants and Cresco restorative components in early and delayed loading protocols at one year post-loading. The treatment groups consist of an early loading and delayed loading arm using Cresco restorative components loading time 10 days post surgery and at 6-8 weeks respectively. The control group comprise the standard delayed loading protocol (healing period 6-8 weeks) and Straumann restorative components. The primary objective is to compare changes in crestal bone levels on radiographs between implants in the control group and test groups at 1 year.The patients will be followed for 3 years.
Sponsor: Institut Straumann AG

Current Primary Outcome: Bone Level Change on Radiographs [ Time Frame: 3 years after loading ]

Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.


Original Primary Outcome: Bone level on radiographs [ Time Frame: 1 year after loading ]

Current Secondary Outcome:

Original Secondary Outcome:

  • implant survival rate [ Time Frame: 1-3 years ]
  • Adverse events [ Time Frame: at every visit during 3 years ]


Information By: Institut Straumann AG

Dates:
Date Received: June 16, 2009
Date Started: October 2004
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016