CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Astra Tech Implant System Profile 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/NCT04712565
NCT04712565N/ACompleted

Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration Without GBR in Comparison to a Conventional Neck Design With GBR-procedure: A Prospective Randomized Clinical Trial

Medical University of Graz·interventional·Posted Jan 15, 2021·Updated Jan 28, 2026

In Brief

A clinical study evaluating Astra Tech Implant System Profile EV and Astra Tech Implant System EV for Tooth Loss. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study is a controlled, randomized clinical trial over about 16-months (active phase). 40 patients in need of replacement of a single tooth with a minimal crestal bone width of 4 - 5mm and suitable for simultaneous GBR (Guided Bone Regeneration) procedure as well as at least a neighboring tooth on its mesial aspect will be consecutively recruited at the Department of Dental Medicine and Oral Health Graz. Volunteers will be screened and eligible subjects will be randomized to two different groups. In group 1 implants with regular neck design (Astra Tech Implant EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) and GBR procedure (BioOss® and BioGide®, Geistlich, Wolhusen, Schweiz) fixed with two membrane pins (Hipp Medical AG, Kolbingen, Germany) will be used; in group 2 implants with sloped marginal configuration (Astra Tech Implant Profile EV C, Dentsply Implants Manufacturing GmbH, Hanau, Germany) without bone augmentation are used. The dimension of the bony defect and amount of lingual-buccal bone height discrepancy (max. 5mm) respectively bone width will be evaluated using a 3-D volume tomography (Planmeca ProMax® 3D Max, Planmeca, Helsinki, Finland), which is needed for digital planning (Simplant Planning Software, Leuven, Belgium) of the implant position, length and diameter as well.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTooth Loss
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 15, 2021
Enrollment StartJan 14, 2021
Primary CompletionSep 11, 2025
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 5.5 years ago

Interventions

Astra Tech Implant System Profile EVdevice

dental implant with a sloped neck configuration

Astra Tech Implant System EVdevice

dental implant with a conventional neck configuration