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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial

Authors: Nicole Passia, Miha Brezavšček, Elfriede Fritzer, Stefanie Kappel, Thomas Kern, Ralph G Luthardt, Nadine Frfr von Maltzahn, Torsten Mundt, Michael Rädel, Axel von Stein-Lausnitz, Matthias Kern

Published in: Trials | Issue 1/2014

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Abstract

Background

Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading.

Methods/design

This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1).

Discussion

This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice.

Trial registration

The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://​www.​germanctr.​de).
Appendix
Available only for authorised users
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Metadata
Title
Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial
Authors
Nicole Passia
Miha Brezavšček
Elfriede Fritzer
Stefanie Kappel
Thomas Kern
Ralph G Luthardt
Nadine Frfr von Maltzahn
Torsten Mundt
Michael Rädel
Axel von Stein-Lausnitz
Matthias Kern
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-186

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