Trial Outcomes & Findings for Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV. (NCT NCT01528215)
NCT ID: NCT01528215
Last Updated: 2020-04-22
Results Overview
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
COMPLETED
NA
120 participants
Evaluated at implant loading and at the 1 year follow-up after implant loading.
2020-04-22
Participant Flow
Participant milestones
| Measure |
OsseoSpeed EV
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
|---|---|---|
|
Enrollment to 1 Year Follow-up
STARTED
|
59
|
61
|
|
Enrollment to 1 Year Follow-up
COMPLETED
|
55
|
60
|
|
Enrollment to 1 Year Follow-up
NOT COMPLETED
|
4
|
1
|
|
1 Year Follow-up to 5 Year Follow-up
STARTED
|
55
|
60
|
|
1 Year Follow-up to 5 Year Follow-up
COMPLETED
|
40
|
45
|
|
1 Year Follow-up to 5 Year Follow-up
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
OsseoSpeed EV
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
|---|---|---|
|
Enrollment to 1 Year Follow-up
Adverse Event
|
4
|
1
|
|
1 Year Follow-up to 5 Year Follow-up
Adverse Event
|
2
|
2
|
|
1 Year Follow-up to 5 Year Follow-up
Lost to Follow-up
|
10
|
13
|
|
1 Year Follow-up to 5 Year Follow-up
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
Baseline characteristics by cohort
| Measure |
OsseoSpeed EV
n=59 Participants
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
n=61 Participants
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 16 • n=5 Participants
|
51 years
STANDARD_DEVIATION 13 • n=7 Participants
|
51 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated at implant loading and at the 1 year follow-up after implant loading.Population: In the EV group, 55 subjects (73 implants) completed the 1 year follow-up visit. In the TX group, 60 subjects (84 implants) completed the 1 year follow-up visit. Three of the radiographs were not possible to evaluate, giving an overall number of 59 subjects (81 implants) as basis for the analysis of marginal bone level change.
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
Outcome measures
| Measure |
OsseoSpeed EV
n=73 Implants
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
n=81 Implants
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
|---|---|---|
|
Marginal Bone Level Change After 1 Year in Use.
|
0.27 Millimeter
Standard Deviation 0.53
|
0.14 Millimeter
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Evaluated from implant loading to the 5 years follow-up after implant loading.Population: In the EV group, 40 subjects (52 implants) completed the 5-year follow-up visit. In the TX group, 45 subjects (64 implants) completed the 5-year follow-up visit.
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Outcome measures
| Measure |
OsseoSpeed EV
n=52 Implants
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
n=64 Implants
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
|---|---|---|
|
Marginal Bone Level Change After 5 Years in Use.
|
0.24 Millimeter
Standard Deviation 0.85
|
0.11 Millimeter
Standard Deviation 0.85
|
Adverse Events
OsseoSpeed EV
OsseoSpeed TX
Serious adverse events
| Measure |
OsseoSpeed EV
n=59 participants at risk
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
|
OsseoSpeed TX
n=61 participants at risk
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
|
|---|---|---|
|
Gastrointestinal disorders
Colitis flare-up
|
1.7%
1/59
|
0.00%
0/61
|
|
Skin and subcutaneous tissue disorders
Basal cell carcinoma
|
1.7%
1/59
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
2/59
|
0.00%
0/61
|
|
Infections and infestations
Infection causing swelling and difficulties swallowing
|
0.00%
0/59
|
1.6%
1/61
|
|
Renal and urinary disorders
Prostate cancer
|
1.7%
1/59
|
1.6%
1/61
|
|
Psychiatric disorders
Depression
|
0.00%
0/59
|
1.6%
1/61
|
|
Cardiac disorders
Abdominal aortic aneurysm
|
0.00%
0/59
|
1.6%
1/61
|
|
Cardiac disorders
Myocardial infarction
|
3.4%
2/59
|
3.3%
2/61
|
|
Reproductive system and breast disorders
Breast cancer
|
1.7%
1/59
|
0.00%
0/61
|
|
Endocrine disorders
Onset of Diabetes
|
1.7%
1/59
|
4.9%
3/61
|
|
Musculoskeletal and connective tissue disorders
Hip surgergy
|
1.7%
1/59
|
0.00%
0/61
|
|
Eye disorders
Torn retina
|
1.7%
1/59
|
0.00%
0/61
|
|
Gastrointestinal disorders
Cyst
|
1.7%
1/59
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Hernia neck
|
1.7%
1/59
|
0.00%
0/61
|
|
Gastrointestinal disorders
Cancer of oesophagus
|
1.7%
1/59
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Fibia fracture
|
1.7%
1/59
|
0.00%
0/61
|
|
Gastrointestinal disorders
Colon cancer
|
0.00%
0/59
|
1.6%
1/61
|
|
General disorders
High bloodpressure
|
0.00%
0/59
|
1.6%
1/61
|
|
Cardiac disorders
Insertion of cardiac stents
|
0.00%
0/59
|
1.6%
1/61
|
|
Cardiac disorders
Premature ventricular contractions (PVC)
|
0.00%
0/59
|
1.6%
1/61
|
|
Nervous system disorders
Death due to cerebral hemorrhage
|
0.00%
0/59
|
1.6%
1/61
|
|
Musculoskeletal and connective tissue disorders
Thumb lost in accident
|
0.00%
0/59
|
1.6%
1/61
|
|
Cardiac disorders
Aortic valve replacement surgery
|
0.00%
0/59
|
1.6%
1/61
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60