Trial Outcomes & Findings for Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading (NCT NCT00748241)
NCT ID: NCT00748241
Last Updated: 2012-02-15
Results Overview
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
COMPLETED
NA
19 participants
At follow-up visit: 6 months after implants have been loaded
2012-02-15
Participant Flow
Participant milestones
| Measure |
Astra Tech Fixture ST
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Astra Tech Fixture ST
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Overall Study
Implant failure
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
Baseline characteristics by cohort
| Measure |
Astra Tech Fixture ST
n=19 Participants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Age Continuous
|
61.0 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At follow-up visit: 6 months after implants have been loadedPopulation: Population includes subjects who completed the 6 month visit (2 subjects missed the 6 month visit but completed the 1 year visit).
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Outcome measures
| Measure |
Astra Tech Fixture ST
n=53 Implants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Implant Survival Rate
|
89.9 Percentage of implants
|
PRIMARY outcome
Timeframe: At follow-up visit: 1 year after implants have been loadedPopulation: Population includes subjects who completed 12 month visit.
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Outcome measures
| Measure |
Astra Tech Fixture ST
n=52 Implants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Implant Survival Rate
|
89.9 Percentage of implants
|
PRIMARY outcome
Timeframe: At follow-up visit: 2 years after implants have been loadedPopulation: Population includes subjects who completed 24 month visit.
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Outcome measures
| Measure |
Astra Tech Fixture ST
n=43 Implants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Implant Survival Rate
|
89.9 Percentage of implants
|
PRIMARY outcome
Timeframe: At follow-up visit: 3 years after implants have been loadedPopulation: Population includes subjects who completed 36 month visit.
An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Outcome measures
| Measure |
Astra Tech Fixture ST
n=39 Implants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Implant Survival Rate
|
89.9 Percentage of implants
|
SECONDARY outcome
Timeframe: 3 years after implant placementPopulation: Number of failed implants based on total number of patients enrolled and total number of placed implants
Total number of implants reported as failure.
Outcome measures
| Measure |
Astra Tech Fixture ST
n=70 Implants
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Implant Failure
|
7 Number of implants
|
Adverse Events
Astra Tech Fixture ST
Serious adverse events
| Measure |
Astra Tech Fixture ST
n=19 participants at risk
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Drug overdose
|
5.3%
1/19 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Head of Clinical Research Area Dental
Astra Tech AB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60