CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
OsseoSpeed EV +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01528215
NCT01528215N/ACompleted
CompareCT.gov

An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.

Dentsply Sirona Implants and Consumables·interventional·Posted Feb 7, 2012·Updated Apr 22, 2020

In Brief

A clinical study evaluating OsseoSpeed EV and OsseoSpeed TX for Partial Edentulism in the Maxilla or in the Mandible. Completed, enrolled 120 participants across 4 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Edentulism in the Maxilla or in the Mandible
CountriesBelgium, Germany, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2012
Enrollment StartNov 1, 2011
Primary CompletionJun 1, 2014
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.4 years ago

Interventions

OsseoSpeed EVdevice

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

OsseoSpeed TXdevice

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm