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Clinical Trial Summary

The purpose of this study is to compare the effect of two different implant abutment designs on gum tissue volume changes over time after implant placement.


Clinical Trial Description

This is a randomized, prospective, controlled clinical trial comparing the facial gingival profiles around Atlantis™ abutments that have either a linear "divergent" or "concave" transitional profile on the facial and proximal aspect of the abutments. Sixty study subjects requiring replacement of a single-rooted tooth with an implant-supported restoration will be recruited. The Osseospeed™ Plus implant will be placed for all 60 subjects, with the use of Uni healing abutments to minimize lateral tissue displacement during healing. After implant placement, but before final impressions are obtained (8 weeks post-placement), subjects will be randomized to either a "divergent" or a "concave" transmucosal abutment design. For fabrication of the experimental abutment, Atlantis™ engineers will initially design a control "divergent" prototype that will be modified with a concavity on the facial and proximal transition zones to obtain an abutment that will otherwise retain all the features of the control abutment. Engineers will measure the linear topographical changes (ΔL=Lc-Ld) of the transition zone, as well as the volumetric change (x) on the mid-facial aspect of the abutment induced by the formation of a submucosal concavity. The primary outcome of the study will be the apico-coronal change of the peri-implant mucosal zenith from prosthesis delivery to one year. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01871220
Study type Interventional
Source University of Iowa
Contact
Status Completed
Phase N/A
Start date December 30, 2013
Completion date October 3, 2018

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