N/A
N=19
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00748241 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
Feb 2012
Primary outcome: Primary: Implant Survival Rate — 89.9 Percentage of implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Astra Tech Fixture ST (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate |
89.9 | — |
| PRIMARY Implant Survival Rate |
89.9 | — |
| PRIMARY Implant Survival Rate |
89.9 | — |
| PRIMARY Implant Survival Rate |
89.9 | — |
| SECONDARY Implant Failure |
7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00748241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.