N/A
N=47
Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00711113 ↗Enrolled (actual)
47
Serious AEs
6.4%
Results posted
Feb 2014
Primary outcome: Primary: Implant Survival Rate — 96.25 percentage of implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate |
96.25 | — |
| PRIMARY Implant Stability |
68.3 | — |
| PRIMARY Marginal Bone Adaptation |
0.3 | — |
Summary
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- 18 years of age and over
- Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
- Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading
Exclusion Criteria
- Untreated caries and/or periodontal disease of residual dentition
- History of edentulism in the area of implant placement of less than two months
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
- Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
- Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- Present alcohol or drug abuse
- Unable or unwilling to return for follow-up visits for a period of 5 years
- Current use of smoking tobacco
- Pregnancy or lactation at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT00711113). 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.