Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial
Identifieur interne : 006924 ( Ncbi/Merge ); précédent : 006923; suivant : 006925Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial
Auteurs : Torsten Mundt [Allemagne] ; Ahmad Al Jaghsi [Allemagne] ; Bernd Schwahn [Allemagne] ; Janina Hilgert [Allemagne] ; Christian Lucas [Allemagne] ; Reiner Biffar [Allemagne] ; Christian Schwahn [Allemagne] ; Friedhelm Heinemann [Allemagne]Source :
- BMC Oral Health [ 1472-6831 ] ; 2016.
Abstract
Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available.
The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications.
Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality.
The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID:
The online version of this article (doi:10.1186/s12903-016-0259-z) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s12903-016-0259-z
PubMed: 27473256
PubMed Central: 4967347
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p>Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available.</p>
</sec>
<sec><title>Methods/design</title>
<p>The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications.</p>
</sec>
<sec><title>Discussion</title>
<p>Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality.</p>
</sec>
<sec><title>Trial registration</title>
<p>The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: <ext-link ext-link-type="uri" xlink:href="https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007589">DRKS00007589</ext-link>
(<ext-link ext-link-type="uri" xlink:href="http://www.germanctr.de">www.germanctr.de</ext-link>
) on January 13<sup>th</sup>
, 2015.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12903-016-0259-z) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Oral Health</journal-id>
<journal-id journal-id-type="iso-abbrev">BMC Oral Health</journal-id>
<journal-title-group><journal-title>BMC Oral Health</journal-title>
</journal-title-group>
<issn pub-type="epub">1472-6831</issn>
<publisher><publisher-name>BioMed Central</publisher-name>
<publisher-loc>London</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27473256</article-id>
<article-id pub-id-type="pmc">4967347</article-id>
<article-id pub-id-type="publisher-id">259</article-id>
<article-id pub-id-type="doi">10.1186/s12903-016-0259-z</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject>
</subj-group>
</article-categories>
<title-group><article-title>Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">http://orcid.org/0000-0001-6231-1902</contrib-id>
<name><surname>Mundt</surname>
<given-names>Torsten</given-names>
</name>
<address><email>mundt@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Al Jaghsi</surname>
<given-names>Ahmad</given-names>
</name>
<address><email>ahmad.aljaghsi@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schwahn</surname>
<given-names>Bernd</given-names>
</name>
<address><email>bschwahn@gmx.net</email>
</address>
<xref ref-type="aff" rid="Aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hilgert</surname>
<given-names>Janina</given-names>
</name>
<address><email>dr.j.hilgert@t-online.de</email>
</address>
<xref ref-type="aff" rid="Aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lucas</surname>
<given-names>Christian</given-names>
</name>
<address><email>lucas@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Biffar</surname>
<given-names>Reiner</given-names>
</name>
<address><email>biffar@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schwahn</surname>
<given-names>Christian</given-names>
</name>
<address><email>schwahn@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Heinemann</surname>
<given-names>Friedhelm</given-names>
</name>
<address><email>friedhelm.heinemann@uni-greifswald.de</email>
</address>
<xref ref-type="aff" rid="Aff5">5</xref>
</contrib>
<aff id="Aff1"><label>1</label>
Department of Prosthodontics, Greifswald University Hospital, Gerodontology and Dental Materials, Greifswald, Germany</aff>
<aff id="Aff2"><label>2</label>
Private Practice, Greifswald, Germany</aff>
<aff id="Aff3"><label>3</label>
Private Practice, Drensteinfurt, Germany</aff>
<aff id="Aff4"><label>4</label>
Department of Oral and Maxillofacial Surgery/Plastic Surgery, Greifswald University Hospital, Greifswald, Germany</aff>
<aff id="Aff5"><label>5</label>
Department of Prosthodontics, Gerodontology and Dental Materials, Private Practice, Morsbach-Lichtenberg, Germany and Greifswald University Hospital, Greifswald, Germany</aff>
</contrib-group>
<pub-date pub-type="epub"><day>30</day>
<month>7</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>30</day>
<month>7</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="collection"><year>2017</year>
</pub-date>
<volume>17</volume>
<elocation-id>30</elocation-id>
<history><date date-type="received"><day>23</day>
<month>2</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>23</day>
<month>7</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>© The Author(s). 2016</copyright-statement>
<license license-type="OpenAccess"><license-p><bold>Open Access</bold>
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>
) applies to the data made available in this article, unless otherwise stated.</license-p>
</license>
</permissions>
<abstract id="Abs1"><sec><title>Background</title>
<p>Acceptable short-term survival rates (>90 %) of mini-implants (diameter < 3.0 mm) are only documented for mandibular overdentures. Sound data for mini-implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available.</p>
</sec>
<sec><title>Methods/design</title>
<p>The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications.</p>
</sec>
<sec><title>Discussion</title>
<p>Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality.</p>
</sec>
<sec><title>Trial registration</title>
<p>The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: <ext-link ext-link-type="uri" xlink:href="https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00007589">DRKS00007589</ext-link>
(<ext-link ext-link-type="uri" xlink:href="http://www.germanctr.de">www.germanctr.de</ext-link>
) on January 13<sup>th</sup>
, 2015.</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12903-016-0259-z) contains supplementary material, which is available to authorized users.</p>
</sec>
</abstract>
<kwd-group xml:lang="en"><title>Keywords</title>
<kwd>Mini dental implant</kwd>
<kwd>Strategic implant</kwd>
<kwd>Partial removable dental prosthesis</kwd>
<kwd>Supplementary abutment</kwd>
<kwd>Implant therapy</kwd>
</kwd-group>
<custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name>
<meta-value>© The Author(s) 2017</meta-value>
</custom-meta>
</custom-meta-group>
</article-meta>
</front>
</pmc>
<affiliations><list><country><li>Allemagne</li>
</country>
</list>
<tree><country name="Allemagne"><noRegion><name sortKey="Mundt, Torsten" sort="Mundt, Torsten" uniqKey="Mundt T" first="Torsten" last="Mundt">Torsten Mundt</name>
</noRegion>
<name sortKey="Al Jaghsi, Ahmad" sort="Al Jaghsi, Ahmad" uniqKey="Al Jaghsi A" first="Ahmad" last="Al Jaghsi">Ahmad Al Jaghsi</name>
<name sortKey="Biffar, Reiner" sort="Biffar, Reiner" uniqKey="Biffar R" first="Reiner" last="Biffar">Reiner Biffar</name>
<name sortKey="Heinemann, Friedhelm" sort="Heinemann, Friedhelm" uniqKey="Heinemann F" first="Friedhelm" last="Heinemann">Friedhelm Heinemann</name>
<name sortKey="Hilgert, Janina" sort="Hilgert, Janina" uniqKey="Hilgert J" first="Janina" last="Hilgert">Janina Hilgert</name>
<name sortKey="Lucas, Christian" sort="Lucas, Christian" uniqKey="Lucas C" first="Christian" last="Lucas">Christian Lucas</name>
<name sortKey="Schwahn, Bernd" sort="Schwahn, Bernd" uniqKey="Schwahn B" first="Bernd" last="Schwahn">Bernd Schwahn</name>
<name sortKey="Schwahn, Christian" sort="Schwahn, Christian" uniqKey="Schwahn C" first="Christian" last="Schwahn">Christian Schwahn</name>
</country>
</tree>
</affiliations>
</record>
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