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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cresco early loading | Experimental | The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery |
|
| Cresco late loading | Experimental | 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. |
|
| Straumann system late loading | Active Comparator | Straumann components loading at 6-8 weeks post surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cresco | Device | Cresco components loading 10 days post surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Level Change on Radiographs | Crestal bone level change at implant margin.The difference between baseline and 3 years after loading. | 3 years after loading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Ellner, DDS, PhD | STP Oral protetik, Kalmar, Sweden | Principal Investigator |
| Asbjorn Jokstad, Professor | University of Toronto, Faculty of Denistry, 124 Edward Street, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| STP Oral protetik | Kalmar | 39185 | Sweden | |||
| Oral rehabilitering |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21435016 | Result | Jokstad A, Ellner S, Gussgard A. Comparison of two early loading protocols in full arch reconstructions in the edentulous maxilla using the Cresco prosthetic system: a three-arm parallel group randomized-controlled trial. Clin Oral Implants Res. 2011 May;22(5):455-63. doi: 10.1111/j.1600-0501.2010.02156.x. Epub 2011 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cresco Early Loading | The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery |
| FG001 | 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. |
| FG002 | Straumann System Late Loading | Straumann components loading at 6-8 weeks post surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cresco Early Loading | The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery |
| BG001 | Cresco Late Loading |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Level Change on Radiographs | Crestal bone level change at implant margin.The difference between baseline and 3 years after loading. | Posted | Mean | Standard Deviation | mm | 3 years after loading |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cresco Early Loading | The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trombosis left leg | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristina Espemar Holst, Senior Clinical Trial Manager | Straumann | +41 61 965 11 11 | info@straumann.com |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| Cresco |
| Device |
Cresco loading at 6-8 weeks post surgery |
|
| Straumann components | Device | Straumann components loading 6-8 weeks post surgery |
|
| Linköping |
| 58185 |
| Sweden |
| Lost to Follow-up |
|
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.
| BG002 | Straumann System Late Loading | Straumann components loading at 6-8 weeks post surgery |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Straumann System Late Loading | Straumann components loading at 6-8 weeks post surgery |
|
|
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 1 | 16 | 0 | 16 |
| EG002 | Straumann System Late Loading | Straumann components loading at 6-8 weeks post surgery | 0 | 10 | 0 | 10 |
| Death | General disorders | Non-systematic Assessment |
|
| Disoriented, depressed | Psychiatric disorders | Non-systematic Assessment | The patient came to the doctor and was depressed and disoriented. She was hospitalised and medicated and the adverse event was resolved without sequelae |
|
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| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |