Cargando…
Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial
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 ye...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4040476/ https://www.ncbi.nlm.nih.gov/pubmed/24884848 http://dx.doi.org/10.1186/1745-6215-15-186 |
_version_ | 1782318576642818048 |
---|---|
author | Passia, Nicole Brezavšček, Miha Fritzer, Elfriede Kappel, Stefanie Kern, Thomas Luthardt, Ralph G Frfr von Maltzahn, Nadine Mundt, Torsten Rädel, Michael von Stein-Lausnitz, Axel Kern, Matthias |
author_facet | Passia, Nicole Brezavšček, Miha Fritzer, Elfriede Kappel, Stefanie Kern, Thomas Luthardt, Ralph G Frfr von Maltzahn, Nadine Mundt, Torsten Rädel, Michael von Stein-Lausnitz, Axel Kern, Matthias |
author_sort | Passia, Nicole |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-4040476 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-40404762014-06-03 Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial Passia, Nicole Brezavšček, Miha Fritzer, Elfriede Kappel, Stefanie Kern, Thomas Luthardt, Ralph G Frfr von Maltzahn, Nadine Mundt, Torsten Rädel, Michael von Stein-Lausnitz, Axel Kern, Matthias Trials Study Protocol 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). BioMed Central 2014-05-24 /pmc/articles/PMC4040476/ /pubmed/24884848 http://dx.doi.org/10.1186/1745-6215-15-186 Text en Copyright © 2014 Passia et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Passia, Nicole Brezavšček, Miha Fritzer, Elfriede Kappel, Stefanie Kern, Thomas Luthardt, Ralph G Frfr von Maltzahn, Nadine Mundt, Torsten Rädel, Michael von Stein-Lausnitz, Axel Kern, Matthias Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title | Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title_full | Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title_fullStr | Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title_full_unstemmed | Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title_short | Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
title_sort | single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4040476/ https://www.ncbi.nlm.nih.gov/pubmed/24884848 http://dx.doi.org/10.1186/1745-6215-15-186 |
work_keys_str_mv | AT passianicole singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT brezavscekmiha singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT fritzerelfriede singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT kappelstefanie singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT kernthomas singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT luthardtralphg singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT frfrvonmaltzahnnadine singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT mundttorsten singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT radelmichael singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT vonsteinlausnitzaxel singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial AT kernmatthias singledentalimplantretainedmandibularcompletedenturesinfluenceoftheloadingprotocolstudyprotocolforarandomizedcontrolledtrial |