Trial Outcomes & Findings for Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants (NCT NCT00922935)
NCT ID: NCT00922935
Last Updated: 2016-03-31
Results Overview
Crestal bone level change at implant margin.The difference between baseline and 3 years after loading.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
3 years after loading
Results posted on
2016-03-31
Participant Flow
Participant milestones
| Measure |
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 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.
|
Straumann System Late Loading
Straumann components loading at 6-8 weeks post surgery
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
16
|
10
|
|
Overall Study
COMPLETED
|
9
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
0
|
Reasons for withdrawal
| Measure |
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 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.
|
Straumann System Late Loading
Straumann components loading at 6-8 weeks post surgery
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants
Baseline characteristics by cohort
| Measure |
Cresco Early Loading
n=10 Participants
The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
|
Cresco Late Loading
n=16 Participants
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
n=10 Participants
Straumann components loading at 6-8 weeks post surgery
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
64.2 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 7 • n=27 Participants
|
65.1 years
STANDARD_DEVIATION 9.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=93 Participants
|
16 participants
n=4 Participants
|
10 participants
n=27 Participants
|
36 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 3 years after loadingCrestal bone level change at implant margin.The difference between baseline and 3 years after loading.
Outcome measures
| Measure |
Cresco Early Loading
n=10 Participants
The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
|
Cresco Late Loading
n=16 Participants
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
n=10 Participants
Straumann components loading at 6-8 weeks post surgery
|
|---|---|---|---|
|
Bone Level Change on Radiographs
|
2.91 mm
Standard Deviation 0.7
|
2.11 mm
Standard Deviation 0.64
|
1.70 mm
Standard Deviation 0.94
|
Adverse Events
Cresco Early Loading
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cresco Late Loading
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Straumann System Late Loading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cresco Early Loading
n=10 participants at risk
The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
|
Cresco Late Loading
n=16 participants at risk
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
n=10 participants at risk
Straumann components loading at 6-8 weeks post surgery
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Trombosis left leg
|
10.0%
1/10 • Number of events 1
|
—
0/0
|
0.00%
0/10
|
|
General disorders
Death
|
0.00%
0/10
|
6.2%
1/16 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Disoriented, depressed
|
0.00%
0/10
|
6.2%
1/16 • Number of events 1
|
0.00%
0/10
|
Other adverse events
Adverse event data not reported
Additional Information
Kristina Espemar Holst, Senior Clinical Trial Manager
Straumann
Phone: +41 61 965 11 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place