Trial Outcomes & Findings for Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges (NCT NCT00710944)
NCT ID: NCT00710944
Last Updated: 2014-07-11
Results Overview
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
COMPLETED
NA
132 participants
12 months after implant placement
2014-07-11
Participant Flow
Participant milestones
| Measure |
Extraction Sockets
Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Healed Ridges
Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Grafted Sites
Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
58
|
19
|
|
Overall Study
COMPLETED
|
45
|
49
|
17
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges
Baseline characteristics by cohort
| Measure |
Extraction Sockets
n=55 Participants
Immediate loading of implants placed in extraction sockets.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Healed Ridges
n=58 Participants
Immediate loading of implants placed in healed ridges.
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Grafted Sites
n=19 Participants
Immediate loading of implants placed in grafted sites (four months healing after grafting).
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 14 • n=5 Participants
|
42 years
STANDARD_DEVIATION 15 • n=7 Participants
|
40 years
STANDARD_DEVIATION 17 • n=5 Participants
|
42 years
STANDARD_DEVIATION 17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 months after implant placementPopulation: Per protocol analysis presented, this includes implants immediately loaded (Group A: 55 implants in 55 subjects, Group B: 58 implants in 58 subjects, Group C: 19 implants in 19 subjects), of these 5 implants in total failed within 12 months after implant placement.
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Outcome measures
| Measure |
Extraction Sockets
n=55 Implants
Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Healed Ridges
n=58 Implants
Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Grafted Sites
n=19 Implants
Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|---|---|
|
Implant Survival
|
94.55 percentage of implants
|
98.28 percentage of implants
|
94.73 percentage of implants
|
Adverse Events
Extractions Sockets
Healed Ridges
Grafted Sites
Serious adverse events
| Measure |
Extractions Sockets
n=55 participants at risk
Immediate loading of implants placed in extraction sockets. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Healed Ridges
n=58 participants at risk
Immediate loading of implants placed in healed ridges. OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
Grafted Sites
n=19 participants at risk
Immediate loading of implants placed in grafted sites (four months healing after grafting).
OsseoSpeed™: OsseoSpeed™ Microthread™ Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Prostate cancer
|
1.8%
1/55
|
0.00%
0/58
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer
|
0.00%
0/55
|
1.7%
1/58
|
0.00%
0/19
|
|
Gastrointestinal disorders
Stomach cancer
|
0.00%
0/55
|
1.7%
1/58
|
0.00%
0/19
|
|
Blood and lymphatic system disorders
Acute lymphangitis
|
1.8%
1/55
|
0.00%
0/58
|
0.00%
0/19
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Manager Global Clinical Research
DENTSPLY Implants
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60