Trials / Completed
CompletedNCT01528215
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Dentsply Sirona Implants and Consumables · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OsseoSpeed EV | OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm |
| DEVICE | OsseoSpeed TX | OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2014-06-01
- Completion
- 2018-04-01
- First posted
- 2012-02-07
- Last updated
- 2020-04-22
- Results posted
- 2016-04-14
Locations
4 sites across 4 countries: United States, Belgium, Germany, Italy
Source: ClinicalTrials.gov record NCT01528215. Inclusion in this directory is not an endorsement.