Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 System on Straumann Implants|
- Bone Level Change on Radiographs [ Time Frame: 3 years after loading ] [ Designated as safety issue: No ]Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.
|Study Start Date:||October 2004|
|Study Completion Date:||September 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Cresco early loading
The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
Cresco components loading 10 days post surgery
Experimental: Cresco late loading
Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before "try ins" to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
Cresco loading at 6-8 weeks post surgery
Active Comparator: Straumann system late loading
Straumann components loading at 6-8 weeks post surgery
Device: Straumann components
Straumann components loading 6-8 weeks post surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922935
|STP Oral protetik|
|Kalmar, Sweden, 39185|
|Linköping, Sweden, 58185|
|Principal Investigator:||Stefan Ellner, DDS, PhD||STP Oral protetik, Kalmar, Sweden|
|Principal Investigator:||Asbjorn Jokstad, Professor||University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto|