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NCT01528215 · ClinicalTrials.gov registry record · NA
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
A NA study, sponsored by Dentsply Sirona Implants and Consumables.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01528215: Completed NA study, sponsored by Dentsply Sirona Implants and Consumables.
NCT01528215 is a NA study that has completed, run by Dentsply Sirona Implants and Consumables. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01528215, a NA study, has completed, sponsored by Dentsply Sirona Implants and Consumables.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
Interventions
- DEVICE OsseoSpeed EV
- DEVICE OsseoSpeed TX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-04 |
| Phase | NA |
What the finished NCT01528215 record still lists
NCT01528215 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which OsseoSpeed EV is the first listed.
NCT01528215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01528215 about?
NCT01528215 is a clinical study titled "Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.". 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 mar...
What is the current status of trial NCT01528215?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2011-11. Estimated completion is 2018-04.
What interventions are being tested in trial NCT01528215?
The interventions under investigation include: OsseoSpeed EV (DEVICE), OsseoSpeed TX (DEVICE).
Who is sponsoring clinical trial NCT01528215?
This trial is sponsored by Dentsply Sirona Implants and Consumables, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01528215's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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