Jaw, Edentulous
Conditions
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 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.
Interventions
DEVICECresco
Cresco components loading 10 days post surgery
DEVICEStraumann components
Straumann components loading 6-8 weeks post surgery
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females must be at least 18 years of age. * Be edentulous in the maxilla and subjectively desire an implant supported screw retained FPD * The teeth at the implant site must have been extracted or lost at least 3 months before the date of implantation. * In the case of Guided Bone Regeneration(GBR) or Guided Tissue Regeneration (GTR) treatments, these procedures must have been completed at least 6 months prior to intended surgery date (to fulfil point 5). * Adequate bone quality and quantity at the six, minimum five, implant sites to permit the insertion of Straumann 4.1 and 3.3 mm diameter implants without the use of concurrent bone augmentation techniques. I.e. implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm of palatal and buccal bone will remain. * Patients must be committed to participate in the study for three years follow-up examinations
Exclusion criteria
* Presence of conditions requiring chronic routine prophylactic use of antibiotics (e. g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) * Medical conditions requiring prolonged use of steroids * History of leukocyte dysfunction and deficiencies * History of bleeding disorders * History of neoplastic disease requiring the use of radiation or chemotherapy * Patients with history of renal failure * Patients with metabolic bone disorders * History of uncontrolled endocrine disorders * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * Use of any investigational drug or device within the 30-day period immediately prior to implant surgery on study day 0. * Alcoholism or drug abuse * Patients infected with HIV * Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco (not greater than 10 cigarette equivalents) * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability. * Local inflammation, including untreated periodontitis * Mucosal diseases such as erosive lichen planus * History of local irradiation therapy * Presence of osseous lesions * Unhealed extraction sites (less than 3 months post extraction of teeth in intended sites) * Bone surgery (bone grafts, guided tissue regeneration technique for bone enhancement) at implant placement. * Severe bruxing or clenching habits * Persistent intraoral infection * Patients with inadequate oral hygiene or unmotivated for adequate home care * Lack of primary stability of 1 or more implant(s) at surgery. In this instance the patient must be withdrawn and treated accordingly. * Insufficient bone * Other: Inability to place implants according to protocol requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Level Change on Radiographs | 3 years after loading | Crestal bone level change at implant margin.The difference between baseline and 3 years after loading. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cresco Early Loading The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery | 10 |
| 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. | 16 |
| Straumann System Late Loading Straumann components loading at 6-8 weeks post surgery | 10 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Cresco Late Loading | Straumann System Late Loading | Cresco Early Loading | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 6 Participants | 3 Participants | 18 Participants |
| Age, Continuous | 64.2 years STANDARD_DEVIATION 10.7 | 67.1 years STANDARD_DEVIATION 7 | 64.1 years STANDARD_DEVIATION 12.2 | 65.1 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Sweden | 16 participants | 10 participants | 10 participants | 36 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 3 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 1 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 16 | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 | 1 / 16 | 0 / 10 |
Outcome results
Primary
Bone Level Change on Radiographs
Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.
Time frame: 3 years after loading
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cresco Early Loading | Bone Level Change on Radiographs | 2.91 mm | Standard Deviation 0.7 |
| Cresco Late Loading | Bone Level Change on Radiographs | 2.11 mm | Standard Deviation 0.64 |
| Straumann System Late Loading | Bone Level Change on Radiographs | 1.70 mm | Standard Deviation 0.94 |