Interaction of titanium, zirconia and lithium disilicate with peri-implant soft tissue: study protocol for a randomized controlled trial
Identifieur interne : 001030 ( Main/Exploration ); précédent : 001029; suivant : 001031Interaction of titanium, zirconia and lithium disilicate with peri-implant soft tissue: study protocol for a randomized controlled trial
Auteurs : Katharina Kuhn [Allemagne] ; Heike Rudolph [Allemagne] ; Michael Graf [Allemagne] ; Matthias Moldan [Allemagne] ; Shaoxia Zhou [Allemagne] ; Martin Udart [Allemagne] ; Andrea Böhmler [Allemagne] ; Ralph G. Luthardt [Allemagne]Source :
- Trials [ 1745-6215 ] ; 2015.
Abstract
Against the background of increasing use of dental implants, and thus an increasing prevalence of implant-associated complications, a deeper understanding of the biomolecular mechanisms in the peri-implant tissue is needed. Peri-implant soft tissue is in direct contact with transmucosal dental implant abutments. The aim of this trial is to distinguish the biomolecular and histological interactions of various dental abutment materials with peri-implant soft tissue.
The study is designed as a prospective, randomized, investigator-initiated clinical pilot trial with blinded assessment. We will ultimately include 24 eligible patients who opt for implant treatment to replace a single missing posterior tooth. Three months after implantation (submerged procedure), the study begins with the second-stage surgery. Each of the 24 patients will be given three different transmucosal abutments (zirconia, lithium disilicate, titanium) consecutively. The sequence in which the three materials are used is randomized. Peri-implant crevicular fluid is sampled weekly around the respective abutment for biomolecular analyses. After one month of wearing time, the stamping press from the second-stage surgery is used to gain a narrow gingival ring biopsy around the abutment for immunohistochemical analyses. The next abutment is then inserted. The same procedure is used for all three abutments. After sampling is completed, the patients will receive a definitive crown. The primary outcome measure of the trial is biomolecular detection of specific markers in the peri-implant crevicular fluid: matrix metalloproteinase 8, interleukin- 1β, polymorphonuclear elastase, and myeloid-related protein MRP8/14 (calprotectin). Secondary outcome measures include immunohistochemical analyses and clinical parameters.
The study design will allow us to perform correlation analyses between the clinical indices with biomarkers’ expression in the interface of the transmucosal abutments and the peri-implant soft tissue. A deeper understanding of the three abutment materials’ interactions with peri-implant soft tissue will help us understand the formation mechanisms of implant-associated complications and then develop prevention strategies.
The trial is registered at the German Clinical Trial Register and the International Clinical Trials Registry Platform by the WHO under
Url:
DOI: 10.1186/s13063-015-0979-4
PubMed: 26470711
PubMed Central: 4608119
Affiliations:
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Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, 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="Rudolph, Heike" sort="Rudolph, Heike" uniqKey="Rudolph H" first="Heike" last="Rudolph">Heike Rudolph</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, 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="Graf, Michael" sort="Graf, Michael" uniqKey="Graf M" first="Michael" last="Graf">Michael Graf</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, 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="Moldan, Matthias" sort="Moldan, Matthias" uniqKey="Moldan M" first="Matthias" last="Moldan">Matthias Moldan</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, 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="Zhou, Shaoxia" sort="Zhou, Shaoxia" uniqKey="Zhou S" first="Shaoxia" last="Zhou">Shaoxia Zhou</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Department of Clinical Chemistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Chemistry, Ulm University, 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="Udart, Martin" sort="Udart, Martin" uniqKey="Udart M" first="Martin" last="Udart">Martin Udart</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Institut für Lasertechnologien in der Medizin und Messtechnik, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institut für Lasertechnologien in der Medizin und Messtechnik, Ulm University, 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="Bohmler, Andrea" sort="Bohmler, Andrea" uniqKey="Bohmler A" first="Andrea" last="Böhmler">Andrea Böhmler</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Institut für Lasertechnologien in der Medizin und Messtechnik, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institut für Lasertechnologien in der Medizin und Messtechnik, Ulm University, 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="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="Aff1">Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, 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></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Against the background of increasing use of dental implants, and thus an increasing prevalence of implant-associated complications, a deeper understanding of the biomolecular mechanisms in the peri-implant tissue is needed. Peri-implant soft tissue is in direct contact with transmucosal dental implant abutments. The aim of this trial is to distinguish the biomolecular and histological interactions of various dental abutment materials with peri-implant soft tissue.</p></sec><sec><title>Methods/Design</title><p>The study is designed as a prospective, randomized, investigator-initiated clinical pilot trial with blinded assessment. We will ultimately include 24 eligible patients who opt for implant treatment to replace a single missing posterior tooth. Three months after implantation (submerged procedure), the study begins with the second-stage surgery. Each of the 24 patients will be given three different transmucosal abutments (zirconia, lithium disilicate, titanium) consecutively. The sequence in which the three materials are used is randomized. Peri-implant crevicular fluid is sampled weekly around the respective abutment for biomolecular analyses. After one month of wearing time, the stamping press from the second-stage surgery is used to gain a narrow gingival ring biopsy around the abutment for immunohistochemical analyses. The next abutment is then inserted. The same procedure is used for all three abutments. After sampling is completed, the patients will receive a definitive crown. The primary outcome measure of the trial is biomolecular detection of specific markers in the peri-implant crevicular fluid: matrix metalloproteinase 8, interleukin- 1β, polymorphonuclear elastase, and myeloid-related protein MRP8/14 (calprotectin). Secondary outcome measures include immunohistochemical analyses and clinical parameters.</p></sec><sec><title>Discussion</title><p>The study design will allow us to perform correlation analyses between the clinical indices with biomarkers’ expression in the interface of the transmucosal abutments and the peri-implant soft tissue. A deeper understanding of the three abutment materials’ interactions with peri-implant soft tissue will help us understand the formation mechanisms of implant-associated complications and then develop prevention strategies.</p></sec><sec><title>Trial registration</title><p>The trial is registered at the German Clinical Trial Register and the International Clinical Trials Registry Platform by the WHO under <ext-link ext-link-type="uri" xlink:href="http://drks-neu.uniklinikfreiburg.de/drks_web/navigate.do;jsessionid=D7DEF9AAF0F982C20DB8019DE0F96D73?navigationId=results">DRKS00006555</ext-link> (Registered on 27 October 2014).</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Lindhe, J" uniqKey="Lindhe J">J Lindhe</name></author><author><name sortKey="Meyle, J" uniqKey="Meyle J">J Meyle</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zitzmann, Nu" uniqKey="Zitzmann 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Grandi</name></author><author><name sortKey="Guazzi, P" uniqKey="Guazzi P">P Guazzi</name></author><author><name sortKey="Samarani, R" uniqKey="Samarani R">R Samarani</name></author><author><name sortKey="Maghaireh, H" uniqKey="Maghaireh H">H Maghaireh</name></author><author><name sortKey="Grandi, G" uniqKey="Grandi G">G Grandi</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bade-Wurtemberg</li><li>District de Tübingen</li></region><settlement><li>Ulm</li></settlement></list><tree><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Kuhn, Katharina" sort="Kuhn, Katharina" uniqKey="Kuhn K" first="Katharina" last="Kuhn">Katharina Kuhn</name></region><name sortKey="Bohmler, Andrea" sort="Bohmler, Andrea" uniqKey="Bohmler A" first="Andrea" last="Böhmler">Andrea Böhmler</name><name sortKey="Graf, Michael" sort="Graf, Michael" uniqKey="Graf M" first="Michael" last="Graf">Michael Graf</name><name sortKey="Luthardt, Ralph G" sort="Luthardt, Ralph G" uniqKey="Luthardt R" first="Ralph G." last="Luthardt">Ralph G. Luthardt</name><name sortKey="Moldan, Matthias" sort="Moldan, Matthias" uniqKey="Moldan M" first="Matthias" last="Moldan">Matthias Moldan</name><name sortKey="Rudolph, Heike" sort="Rudolph, Heike" uniqKey="Rudolph H" first="Heike" last="Rudolph">Heike Rudolph</name><name sortKey="Udart, Martin" sort="Udart, Martin" uniqKey="Udart M" first="Martin" last="Udart">Martin Udart</name><name sortKey="Zhou, Shaoxia" sort="Zhou, Shaoxia" uniqKey="Zhou S" first="Shaoxia" last="Zhou">Shaoxia Zhou</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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