Trial Outcomes & Findings for Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw (NCT NCT00545818)
NCT ID: NCT00545818
Last Updated: 2020-05-19
Results Overview
Marginal Bone Level determined from radiographs and expressed as the difference 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 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
COMPLETED
NA
97 participants
Evaluated from implant installation to 5 years follow-up after implant placement
2020-05-19
Participant Flow
97 subjects were enrolled in the study (singed informed consent).Two of those subjects fulfilled exclusion criteria and were removed from the study population before randomization. As a consequence a total of 95 subjects were randomised (assigned to groups) and received study treatment.
Unit of analysis: Implants
Participant milestones
| Measure |
Group-1, Implant Length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Overall Study
STARTED
|
49 108
|
46 101
|
|
Overall Study
COMPLETED
|
46 98
|
39 86
|
|
Overall Study
NOT COMPLETED
|
3 10
|
7 15
|
Reasons for withdrawal
| Measure |
Group-1, Implant Length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
6
|
Baseline Characteristics
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Baseline characteristics by cohort
| Measure |
Group-1, Implant Length 6 mm
n=49 Participants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=46 Participants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 9.39 • n=99 Participants
|
54.1 years
STANDARD_DEVIATION 10.04 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 9.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
14 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Evaluated from implant installation to 5 years follow-up after implant placementPopulation: A total of 85 subjects (184 implants) completed the study. For a total of 10 implants (in 5 subjects) the quality of the radiographs were not sufficient for reading, giving a total of 80 subjects (174 implants) for the analysis of MBL change.
Marginal Bone Level determined from radiographs and expressed as the difference 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 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
Outcome measures
| Measure |
Group-1, Implant Length 6 mm
n=94 Implants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=80 Implants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Radiological Assessments of Marginal Bone Level Alteration
|
0.02 millimeter
Standard Deviation 0.52
|
-0.18 millimeter
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Evaluated 5 years after implant placementPopulation: Group-1. A total of 49 subjects (108 positions) underwent surgery. Three positions were not implanted due to complications during surgery. Giving a total 105 implants installed. Group-2. A total of 46 subjects (101 positions) underwent surgery. Giving a total of 101 implants installed.
Overall implant survival, measured on implant level
Outcome measures
| Measure |
Group-1, Implant Length 6 mm
n=105 implants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=101 implants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Overall Implant Survival
|
101 implants
|
100 implants
|
SECONDARY outcome
Timeframe: Measured at the 5-year follow-up visit after loadingPopulation: A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of BoP.
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.
Outcome measures
| Measure |
Group-1, Implant Length 6 mm
n=98 implants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=86 implants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
|
43 implants
|
28 implants
|
SECONDARY outcome
Timeframe: Evaluated at implant loading and at the 5-year follow-up visit.Population: A total of 85 subjects (184 implants) completed the 5-year follow-up visit. Group-1. For 3 subjects (7 implants) the radiographs were not possible to evaluate, giving a total of 43 subjects (91 implants) being available for evaluation of change in PPD. Group-2. All radiographs readable, giving 39 subjects (86 positions) for the evaluation.
Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Outcome measures
| Measure |
Group-1, Implant Length 6 mm
n=91 implants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=86 implants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
|
-0.57 millimeters
Standard Deviation 0.92
|
-1.11 millimeters
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Evaluated at the 5-year follow-up visit after loading.Population: A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of presence of plaque.
Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.
Outcome measures
| Measure |
Group-1, Implant Length 6 mm
n=98 implants
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=86 implants
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Presence of Plaque
|
16 implants
|
6 implants
|
Adverse Events
Group-1, Implant Length 6 mm
Group-2, Implant Length 11 mm
Serious adverse events
| Measure |
Group-1, Implant Length 6 mm
n=49 participants at risk
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=46 participants at risk
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteopaenia, trauma - fractured toes
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Renal and urinary disorders
Insufficient renal function (30%)
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Vascular disorders
Arteriosclerosis
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Cardiac disorders
Undefined heart problems
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Product Issues
Failure knee-prosthesis
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hip function failure
|
2.0%
1/49 • Number of events 2 • 5 years
|
0.00%
0/46 • 5 years
|
|
Hepatobiliary disorders
Gallbladder removed
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Infections and infestations
Right hip replacement, post-op infection
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Infections and infestations
Armpit abscess due to spider bite.
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Infections and infestations
Bilateral toe infection
|
2.0%
1/49 • Number of events 1 • 5 years
|
0.00%
0/46 • 5 years
|
|
Hepatobiliary disorders
Liver cancer
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
General disorders
Death
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Broken pelvis
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis - Non Hodgkin disease
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Hip fracture due to car accident
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Ovarian cancer
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Eye disorders
Eye cancer (basal cell carcinoma)
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 2 • 5 years
|
|
Skin and subcutaneous tissue disorders
Squamous cell skin cancer
|
0.00%
0/49 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Group-1, Implant Length 6 mm
n=49 participants at risk
Subjects treated with OsseoSpeed™ implant, length: 6 mm
|
Group-2, Implant Length 11 mm
n=46 participants at risk
Subjects treated with OsseoSpeed™ implant, length: 11 mm
|
|---|---|---|
|
Product Issues
Study implant failure
|
10.2%
5/49 • Number of events 5 • 5 years
|
2.2%
1/46 • Number of events 1 • 5 years
|
|
Product Issues
Bridge screw loosening
|
10.2%
5/49 • Number of events 5 • 5 years
|
10.9%
5/46 • Number of events 10 • 5 years
|
|
Product Issues
Abutment fracture
|
2.0%
1/49 • Number of events 4 • 5 years
|
6.5%
3/46 • Number of events 3 • 5 years
|
|
Product Issues
Fracture of temporary bridge
|
4.1%
2/49 • Number of events 3 • 5 years
|
6.5%
3/46 • Number of events 3 • 5 years
|
Additional Information
Manager Global Clinical Research
Dentsply Sirona Implants, Mölndal, SWEDEN
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60