Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.
1 other identifier
interventional
19
1 country
2
Brief Summary
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 5, 2008
CompletedFirst Posted
Study publicly available on registry
September 8, 2008
CompletedResults Posted
Study results publicly available
February 15, 2012
CompletedFebruary 15, 2012
January 1, 2012
7.9 years
September 5, 2008
August 23, 2011
January 12, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
Implant Survival Rate
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.
At follow-up visit: 6 months after implants have been loaded
Implant Survival Rate
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.
At follow-up visit: 1 year after implants have been loaded
Implant Survival Rate
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.
At follow-up visit: 2 years after implants have been loaded
Implant Survival Rate
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.
At follow-up visit: 3 years after implants have been loaded
Secondary Outcomes (1)
Implant Failure
3 years after implant placement
Study Arms (1)
Astra Tech Fixture ST
EXPERIMENTALInterventions
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Eligibility Criteria
You may qualify if:
- Age 18 - 75
- Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
- Willing to give informed consent
You may not qualify if:
- Bone height \< 5 mm, in the planned implant area
- Bone width \< 5 mm, in the planned implant area
- Previous bone augmentation procedure in the planned implant area
- Previous failures of endosseous implants
- Untreated caries and/or periodontal disease of residual dentition
- History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Current alcohol or drug abuse
- Unable or unwilling to return for follow-up visits for 3 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
New York, New York, 10010, United States
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Research Area Dental
- Organization
- Astra Tech AB
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce G Valauri, D.D.S.
New York Dept of Veterans Affairs Medical Center
- PRINCIPAL INVESTIGATOR
Michael Toffler, D.D.S.
New York Dept of Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2008
First Posted
September 8, 2008
Study Start
September 1, 2000
Primary Completion
August 1, 2008
Last Updated
February 15, 2012
Results First Posted
February 15, 2012
Record last verified: 2012-01