Early loading of plalatal implants (ortho-type II) a prospective multicenter randomized controlled clinical trial
Identifieur interne : 006741 ( Main/Exploration ); précédent : 006740; suivant : 006742Early loading of plalatal implants (ortho-type II) a prospective multicenter randomized controlled clinical trial
Auteurs : Britta A. Jung [Allemagne] ; Heinrich Wehrbein [Allemagne] ; Werner Hopfenmüller [Allemagne] ; Winfried Harzer [Allemagne] ; Tomasz Gedrange [Allemagne] ; Peter Diedrich [Allemagne] ; Martin Kunkel [Allemagne]Source :
- Trials [ 1745-6215 ] ; 2007.
Abstract
In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage.
The intended study is designed as a prospective, multicenter randomized controlled trial (RCT), comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland).
124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard), whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement.
The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone evaluation of all retrieved implants. Additionally, resonance frequency analysis (RFA, Osstell™ mentor) will be used at different times for clinically monitoring the implant stability and for histological comparison in order to measure the reliability of the resonance frequency measuring device.
Current Controlled Trials ISRCTN97142521.
Url:
DOI: 10.1186/1745-6215-8-24
PubMed: 17883841
PubMed Central: 2039736
Affiliations:
- Allemagne
- Berlin, District de Cologne, District de Dresde, Rhénanie-du-Nord-Westphalie, Saxe (Land)
- Aix-la-Chapelle, Berlin, Dresde
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Le document en format XML
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Jung</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Orthodontics, University Hospital Mainz, Augustusplatz 2, 55131 Mainz, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Orthodontics, University Hospital Mainz, Augustusplatz 2, 55131 Mainz</wicri:regionArea><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion></affiliation></author><author><name sortKey="Wehrbein, Heinrich" sort="Wehrbein, Heinrich" uniqKey="Wehrbein H" first="Heinrich" last="Wehrbein">Heinrich Wehrbein</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Orthodontics, University Hospital Mainz, Augustusplatz 2, 55131 Mainz, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Orthodontics, University Hospital Mainz, Augustusplatz 2, 55131 Mainz</wicri:regionArea><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion></affiliation></author><author><name sortKey="Hopfenmuller, Werner" sort="Hopfenmuller, Werner" uniqKey="Hopfenmuller W" first="Werner" last="Hopfenmüller">Werner Hopfenmüller</name><affiliation wicri:level="3"><nlm:aff id="I2">Institute for Medical Statistics, Charité-Campus Benjamin Franklin, University of Berlin, Hindenburgdamm 30, 12203 Berlin, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute for Medical Statistics, Charité-Campus Benjamin Franklin, University of Berlin, Hindenburgdamm 30, 12203 Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Harzer, Winfried" sort="Harzer, Winfried" uniqKey="Harzer W" first="Winfried" last="Harzer">Winfried Harzer</name><affiliation wicri:level="3"><nlm:aff id="I3">Department of Orthodontics, Technical University of Dresden, Fetscherstr. 74, 01307 Dresden, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Orthodontics, Technical University of Dresden, Fetscherstr. 74, 01307 Dresden</wicri:regionArea><placeName><region type="land" nuts="1">Saxe (Land)</region><region type="district" nuts="2">District de Dresde</region><settlement type="city">Dresde</settlement></placeName></affiliation></author><author><name sortKey="Gedrange, Tomasz" sort="Gedrange, Tomasz" uniqKey="Gedrange T" first="Tomasz" last="Gedrange">Tomasz Gedrange</name><affiliation wicri:level="1"><nlm:aff id="I4">Department of Orthodontics, University of Greifswald, Rotgerberstr. 8, 17487 Greifswald, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Orthodontics, University of Greifswald, Rotgerberstr. 8, 17487 Greifswald</wicri:regionArea><wicri:noRegion>17487 Greifswald</wicri:noRegion><wicri:noRegion>17487 Greifswald</wicri:noRegion><wicri:noRegion>17487 Greifswald</wicri:noRegion></affiliation></author><author><name sortKey="Diedrich, Peter" sort="Diedrich, Peter" uniqKey="Diedrich P" first="Peter" last="Diedrich">Peter Diedrich</name><affiliation wicri:level="3"><nlm:aff id="I5">Department of Orthodontics, University of Aachen, Pauwelsstr. 30, 52074 Aachen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Orthodontics, University of Aachen, Pauwelsstr. 30, 52074 Aachen</wicri:regionArea><placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Cologne</region><settlement type="city">Aix-la-Chapelle</settlement></placeName></affiliation></author><author><name sortKey="Kunkel, Martin" sort="Kunkel, Martin" uniqKey="Kunkel M" first="Martin" last="Kunkel">Martin Kunkel</name><affiliation wicri:level="1"><nlm:aff id="I6">Department of Oral and Maxillofacial Surgery, University Hospital Mainz, Augustusplatz 2, 55131 Mainz, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Oral and Maxillofacial Surgery, University Hospital Mainz, Augustusplatz 2, 55131 Mainz</wicri:regionArea><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion><wicri:noRegion>55131 Mainz</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage.</p></sec><sec><title>Methods/Design</title><p>The intended study is designed as a prospective, multicenter randomized controlled trial (RCT), comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland).</p><p>124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard), whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement.</p><p>The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone evaluation of all retrieved implants. Additionally, resonance frequency analysis (RFA, Osstell™ mentor) will be used at different times for clinically monitoring the implant stability and for histological comparison in order to measure the reliability of the resonance frequency measuring device.</p></sec><sec><title>Trial registration</title><p>Current Controlled Trials ISRCTN97142521.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Berlin</li><li>District de Cologne</li><li>District de Dresde</li><li>Rhénanie-du-Nord-Westphalie</li><li>Saxe (Land)</li></region><settlement><li>Aix-la-Chapelle</li><li>Berlin</li><li>Dresde</li></settlement></list><tree><country name="Allemagne"><noRegion><name sortKey="Jung, Britta A" sort="Jung, Britta A" uniqKey="Jung B" first="Britta A" last="Jung">Britta A. Jung</name></noRegion><name sortKey="Diedrich, Peter" sort="Diedrich, Peter" uniqKey="Diedrich P" first="Peter" last="Diedrich">Peter Diedrich</name><name sortKey="Gedrange, Tomasz" sort="Gedrange, Tomasz" uniqKey="Gedrange T" first="Tomasz" last="Gedrange">Tomasz Gedrange</name><name sortKey="Harzer, Winfried" sort="Harzer, Winfried" uniqKey="Harzer W" first="Winfried" last="Harzer">Winfried Harzer</name><name sortKey="Hopfenmuller, Werner" sort="Hopfenmuller, Werner" uniqKey="Hopfenmuller W" first="Werner" last="Hopfenmüller">Werner Hopfenmüller</name><name sortKey="Kunkel, Martin" sort="Kunkel, Martin" uniqKey="Kunkel M" first="Martin" last="Kunkel">Martin Kunkel</name><name sortKey="Wehrbein, Heinrich" sort="Wehrbein, Heinrich" uniqKey="Wehrbein H" first="Heinrich" last="Wehrbein">Heinrich Wehrbein</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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