NCT00922935

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

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 System on Straumann Implants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Jaw, Edentulous

Interventions

Type	Name	Description
DEVICE	Cresco	Cresco components loading 10 days post surgery
DEVICE	Cresco	Cresco loading at 6-8 weeks post surgery
DEVICE	Straumann components	Straumann components loading 6-8 weeks post surgery

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-02-01
• Completion: 2009-09-01
• First posted: 2009-06-17
• Last updated: 2016-03-31
• Results posted: 2011-07-12

Locations

2 sites across 1 country: Sweden