Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial
Identifieur interne : 000401 ( Main/Exploration ); précédent : 000400; suivant : 000402Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial
Auteurs : Nicole Passia [Allemagne] ; Miha Brezavš Ek [Allemagne] ; Elfriede Fritzer [Allemagne] ; Stefanie Kappel [Allemagne] ; Thomas Kern [Allemagne] ; Ralph G. Luthardt [Allemagne] ; Nadine Frfr Von Maltzahn [Allemagne] ; Torsten Mundt [Allemagne] ; Michael R Del [Allemagne] ; Axel Von Stein-Lausnitz [Allemagne] ; Matthias Kern [Allemagne]Source :
- Trials [ 1745-6215 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Allemagne, Analyse du stress dentaire, Conception de prothèse dentaire, Contrainte mécanique, Facteurs temps, Femelle, Humains, Mandibule (), Mâchoire édentée (), Mâle, Overdenture, Plan de recherche, Pose d'implant dentaire (), Pose d'implant dentaire (effets indésirables), Pose d'implant dentaire (instrumentation), Prothèse dentaire implanto-portée, Protocoles cliniques, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Échec de restauration dentaire, Études prospectives.
- MESH :
- effets indésirables : Pose d'implant dentaire.
- Adulte d'âge moyen, Allemagne, Analyse du stress dentaire, Conception de prothèse dentaire, Contrainte mécanique, Facteurs temps, Femelle, Humains, Mandibule, Mâchoire édentée, Mâle, Overdenture, Plan de recherche, Pose d'implant dentaire, Prothèse dentaire implanto-portée, Protocoles cliniques, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Échec de restauration dentaire, Études prospectives.
- Wicri :
- geographic : Allemagne.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Clinical Protocols, Dental Implantation (adverse effects), Dental Implantation (instrumentation), Dental Implantation (methods), Dental Prosthesis Design, Dental Prosthesis, Implant-Supported, Dental Restoration Failure, Dental Stress Analysis, Denture, Overlay, Female, Germany, Humans, Jaw, Edentulous (surgery), Male, Mandible (surgery), Middle Aged, Prospective Studies, Research Design, Stress, Mechanical, Time Factors, Treatment Outcome.
- MESH :
- geographic : Germany.
- adverse effects : Dental Implantation.
- instrumentation : Dental Implantation.
- methods : Dental Implantation.
- surgery : Jaw, Edentulous, Mandible.
- Aged, Aged, 80 and over, Clinical Protocols, Dental Prosthesis Design, Dental Prosthesis, Implant-Supported, Dental Restoration Failure, Dental Stress Analysis, Denture, Overlay, Female, Humans, Male, Middle Aged, Prospective Studies, Research Design, Stress, Mechanical, Time Factors, Treatment Outcome.
Abstract
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.
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).
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.
The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID:
Url:
DOI: 10.1186/1745-6215-15-186
PubMed: 24884848
PubMed Central: 4040476
Affiliations:
- Allemagne
- Bade-Wurtemberg, Basse-Saxe, District de Cologne, District de Dresde, District de Fribourg-en-Brisgau, District de Karlsruhe, District de Tübingen, Hambourg, Rhénanie-du-Nord-Westphalie, Saxe (Land), Schleswig-Holstein
- Aix-la-Chapelle, Dresde, Fribourg-en-Brisgau, Hambourg, Hanovre, Heidelberg, Kiel, Ulm
Links toward previous steps (curation, corpus...)
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Le document en format XML
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xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University of Kiel, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Brezavs Ek, Miha" sort="Brezavs Ek, Miha" uniqKey="Brezavs Ek M" first="Miha" last="Brezavš Ek">Miha Brezavš Ek</name><affiliation wicri:level="3"><nlm:aff id="I2">Department of Prosthetic Dentistry, University Hospital Freiburg, Freiburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, University Hospital Freiburg, Freiburg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Fribourg-en-Brisgau</region><settlement type="city">Fribourg-en-Brisgau</settlement></placeName></affiliation></author><author><name sortKey="Fritzer, Elfriede" sort="Fritzer, Elfriede" uniqKey="Fritzer E" first="Elfriede" last="Fritzer">Elfriede Fritzer</name><affiliation wicri:level="3"><nlm:aff id="I3">Center for Clinical Studies, Christian-Albrechts University of Kiel, Kiel, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Center for Clinical Studies, Christian-Albrechts University of Kiel, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Kappel, Stefanie" sort="Kappel, Stefanie" uniqKey="Kappel S" first="Stefanie" last="Kappel">Stefanie Kappel</name><affiliation wicri:level="3"><nlm:aff id="I4">Department of Prosthodontics, Heidelberg University Hospital, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthodontics, Heidelberg University Hospital, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Kern, Thomas" sort="Kern, Thomas" uniqKey="Kern T" first="Thomas" last="Kern">Thomas Kern</name><affiliation wicri:level="3"><nlm:aff id="I5">Department of Prosthodontics and Biomaterials, University Hospital Aachen, Aachen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthodontics and Biomaterials, University Hospital Aachen, 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="Luthardt, Ralph G" sort="Luthardt, Ralph G" uniqKey="Luthardt R" first="Ralph G" last="Luthardt">Ralph G. Luthardt</name><affiliation wicri:level="3"><nlm:aff id="I6">Center of Dentistry, Department of Prosthetic Dentistry, Ulm University Hospital, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Center of Dentistry, Department of Prosthetic Dentistry, Ulm University Hospital, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author><author><name sortKey="Frfr Von Maltzahn, Nadine" sort="Frfr Von Maltzahn, Nadine" uniqKey="Frfr Von Maltzahn N" first="Nadine" last="Frfr Von Maltzahn">Nadine Frfr Von Maltzahn</name><affiliation wicri:level="3"><nlm:aff id="I7">Department of Prosthodontics, University Hospital Hannover, Hannover, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthodontics, University Hospital Hannover, Hannover</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Hanovre</settlement></placeName></affiliation></author><author><name sortKey="Mundt, Torsten" sort="Mundt, Torsten" uniqKey="Mundt T" first="Torsten" last="Mundt">Torsten Mundt</name><affiliation wicri:level="1"><nlm:aff id="I8">Department of Prosthetic Dentistry, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Ernst-Moritz-Arndt University of Greifswald, Greifswald</wicri:regionArea><wicri:noRegion>Greifswald</wicri:noRegion><wicri:noRegion>Greifswald</wicri:noRegion><wicri:noRegion>Greifswald</wicri:noRegion></affiliation></author><author><name sortKey="R Del, Michael" sort="R Del, Michael" uniqKey="R Del M" first="Michael" last="R Del">Michael R Del</name><affiliation wicri:level="3"><nlm:aff id="I9">Department of Prosthetic Dentistry, Dresden University of Technology, Medical Faculty Carl Gustav Carus, Dresden, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Dresden University of Technology, Medical Faculty Carl Gustav Carus, 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="Von Stein Lausnitz, Axel" sort="Von Stein Lausnitz, Axel" uniqKey="Von Stein Lausnitz A" first="Axel" last="Von Stein-Lausnitz">Axel Von Stein-Lausnitz</name><affiliation wicri:level="3"><nlm:aff id="I10">Center for Dental and Oral Medicine, Department of Dental Prosthetics, University Medical Center Hamburg Eppendorf, Hamburg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Center for Dental and Oral Medicine, Department of Dental Prosthetics, University Medical Center Hamburg Eppendorf, Hamburg</wicri:regionArea><placeName><settlement type="city">Hambourg</settlement><region type="land" nuts="2">Hambourg</region></placeName></affiliation></author><author><name sortKey="Kern, Matthias" sort="Kern, Matthias" uniqKey="Kern M" first="Matthias" last="Kern">Matthias Kern</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University of Kiel, Kiel, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University of Kiel, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date 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dentaire</term><term>Conception de prothèse dentaire</term><term>Contrainte mécanique</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mandibule ()</term><term>Mâchoire édentée ()</term><term>Mâle</term><term>Overdenture</term><term>Plan de recherche</term><term>Pose d'implant dentaire ()</term><term>Pose d'implant dentaire (effets indésirables)</term><term>Pose d'implant dentaire (instrumentation)</term><term>Prothèse dentaire implanto-portée</term><term>Protocoles cliniques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Échec de restauration dentaire</term><term>Études prospectives</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Germany</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Dental Implantation</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Pose d'implant dentaire</term></keywords><keywords scheme="MESH" qualifier="instrumentation" xml:lang="en"><term>Dental Implantation</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Dental Implantation</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Jaw, Edentulous</term><term>Mandible</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Clinical Protocols</term><term>Dental Prosthesis Design</term><term>Dental Prosthesis, Implant-Supported</term><term>Dental Restoration Failure</term><term>Dental Stress Analysis</term><term>Denture, Overlay</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Research Design</term><term>Stress, Mechanical</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Allemagne</term><term>Analyse du stress dentaire</term><term>Conception de prothèse dentaire</term><term>Contrainte mécanique</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mandibule</term><term>Mâchoire édentée</term><term>Mâle</term><term>Overdenture</term><term>Plan de recherche</term><term>Pose d'implant dentaire</term><term>Prothèse dentaire implanto-portée</term><term>Protocoles cliniques</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Échec de restauration dentaire</term><term>Études prospectives</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Allemagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods/design</title><p>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).</p></sec><sec><title>Discussion</title><p>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.</p></sec><sec><title>Trial registration</title><p>The trial has been 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=DRKS00003730">DRKS00003730</ext-link> since 23 August 2012. (<ext-link ext-link-type="uri" xlink:href="http://www.germanctr.de">http://www.germanctr.de</ext-link>).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Micheelis, W" uniqKey="Micheelis W">W Micheelis</name></author><author><name sortKey="Schiffner, U" uniqKey="Schiffner U">U Schiffner</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Feine, Js" uniqKey="Feine J">JS Feine</name></author><author><name sortKey="Carlsson, Ge" uniqKey="Carlsson G">GE Carlsson</name></author><author><name sortKey="Awad, Ma" uniqKey="Awad M">MA Awad</name></author><author><name sortKey="Chehade, A" uniqKey="Chehade A">A Chehade</name></author><author><name sortKey="Duncan, Wj" uniqKey="Duncan W">WJ Duncan</name></author><author><name sortKey="Gizani, S" uniqKey="Gizani S">S Gizani</name></author><author><name sortKey="Head, T" uniqKey="Head T">T Head</name></author><author><name sortKey="Lund, Jp" uniqKey="Lund J">JP Lund</name></author><author><name sortKey="Macentee, M" uniqKey="Macentee M">M MacEntee</name></author><author><name sortKey="Mericske Stern, R" uniqKey="Mericske Stern R">R Mericske-Stern</name></author><author><name sortKey="Mojon, P" uniqKey="Mojon P">P Mojon</name></author><author><name sortKey="Morais, J" uniqKey="Morais J">J Morais</name></author><author><name sortKey="Naert, I" uniqKey="Naert I">I Naert</name></author><author><name sortKey="Payne, Ag" uniqKey="Payne A">AG Payne</name></author><author><name sortKey="Penrod, J" uniqKey="Penrod J">J Penrod</name></author><author><name sortKey="Stoker, Gt" uniqKey="Stoker G">GT Stoker</name></author><author><name sortKey="Tawse Smith, A" uniqKey="Tawse Smith A">A Tawse-Smith</name></author><author><name sortKey="Taylor, Td" uniqKey="Taylor T">TD Taylor</name></author><author><name sortKey="Thomason, Jm" uniqKey="Thomason J">JM Thomason</name></author><author><name sortKey="Thomson, Wm" uniqKey="Thomson W">WM 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uniqKey="Bosman F">F Bosman</name></author><author><name sortKey="Kleizen, Hh" uniqKey="Kleizen H">HH Kleizen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Blackwelder, Wc" uniqKey="Blackwelder W">WC Blackwelder</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Krennmair, G" uniqKey="Krennmair G">G Krennmair</name></author><author><name sortKey="Ulm, C" uniqKey="Ulm C">C Ulm</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Liddelow, G" uniqKey="Liddelow G">G Liddelow</name></author><author><name sortKey="Henry, P" uniqKey="Henry P">P Henry</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Harder, S" uniqKey="Harder S">S Harder</name></author><author><name sortKey="Wolfart, S" uniqKey="Wolfart S">S Wolfart</name></author><author><name sortKey="Egert, C" uniqKey="Egert C">C Egert</name></author><author><name sortKey="Kern, M" uniqKey="Kern M">M Kern</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Passia, N" uniqKey="Passia N">N Passia</name></author><author><name sortKey="Wolfart, S" uniqKey="Wolfart S">S Wolfart</name></author><author><name sortKey="Kern, M" uniqKey="Kern M">M Kern</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bade-Wurtemberg</li><li>Basse-Saxe</li><li>District de Cologne</li><li>District de Dresde</li><li>District de Fribourg-en-Brisgau</li><li>District de Karlsruhe</li><li>District de Tübingen</li><li>Hambourg</li><li>Rhénanie-du-Nord-Westphalie</li><li>Saxe (Land)</li><li>Schleswig-Holstein</li></region><settlement><li>Aix-la-Chapelle</li><li>Dresde</li><li>Fribourg-en-Brisgau</li><li>Hambourg</li><li>Hanovre</li><li>Heidelberg</li><li>Kiel</li><li>Ulm</li></settlement></list><tree><country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Passia, Nicole" sort="Passia, Nicole" uniqKey="Passia N" first="Nicole" last="Passia">Nicole Passia</name></region><name sortKey="Brezavs Ek, Miha" sort="Brezavs Ek, Miha" uniqKey="Brezavs Ek M" first="Miha" last="Brezavš Ek">Miha Brezavš Ek</name><name sortKey="Frfr Von Maltzahn, Nadine" sort="Frfr Von Maltzahn, Nadine" uniqKey="Frfr Von Maltzahn N" first="Nadine" last="Frfr Von Maltzahn">Nadine Frfr Von Maltzahn</name><name sortKey="Fritzer, Elfriede" sort="Fritzer, Elfriede" uniqKey="Fritzer E" first="Elfriede" last="Fritzer">Elfriede Fritzer</name><name sortKey="Kappel, Stefanie" sort="Kappel, Stefanie" uniqKey="Kappel S" first="Stefanie" last="Kappel">Stefanie Kappel</name><name sortKey="Kern, Matthias" sort="Kern, Matthias" uniqKey="Kern M" first="Matthias" last="Kern">Matthias Kern</name><name sortKey="Kern, Thomas" sort="Kern, Thomas" uniqKey="Kern T" first="Thomas" last="Kern">Thomas Kern</name><name sortKey="Luthardt, Ralph G" sort="Luthardt, Ralph G" uniqKey="Luthardt R" first="Ralph G" last="Luthardt">Ralph G. Luthardt</name><name sortKey="Mundt, Torsten" sort="Mundt, Torsten" uniqKey="Mundt T" first="Torsten" last="Mundt">Torsten Mundt</name><name sortKey="R Del, Michael" sort="R Del, Michael" uniqKey="R Del M" first="Michael" last="R Del">Michael R Del</name><name sortKey="Von Stein Lausnitz, Axel" sort="Von Stein Lausnitz, Axel" uniqKey="Von Stein Lausnitz A" first="Axel" last="Von Stein-Lausnitz">Axel Von Stein-Lausnitz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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