Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology
7. december 2015 opdateret af: Julio Carrion, Stony Brook University
An In Vivo Assessment of the Effects of Using Different Implant Abutment Occluding Materials on Implant Microleakage and the Peri-Implant Microbiome
The primary purpose of this study is to determine what effect, if any, do different dental materials used to seal the prosthetic screw channels of implant supported restorations have on dental implant health parameters and microbiology.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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New York
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Stony Brook, New York, Forenede Stater, 11794
- School of Dental Medicine of Stony Brook University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Fully edentulous patient
- Patient has at least one arch restored with a full-arch dental supported prosthesis
Exclusion Criteria:
- poor oral hygiene and motivation (as determined with prosthesis in place)
- uncontrolled diabetes
- pregnant or lactating
- substance abusers
- current smokers
- psychiatric problems or unrealistic expectations
- acute infection in the area intended for implant sealing
- positive to HIV and hepatitis B and C
- affected by autoimmune diseases
- under chronic treatment with steroids or non-steroidal anti-inflammatory drugs.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Dental Materials
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Andre navne:
Andre navne:
Andre navne:
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sonderende dybde
Tidsramme: 6 måneder
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6 måneder
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Gingival Index
Tidsramme: 6 Months
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6 Months
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Plaque Index
Tidsramme: 6 Months
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6 Months
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Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols
Tidsramme: 6 Months
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6 Months
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Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols
Tidsramme: 6 Months
|
6 Months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Julio A Carrion, DMD, PhD, Stony Brook University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Broggini N, McManus LM, Hermann JS, Medina R, Schenk RK, Buser D, Cochran DL. Peri-implant inflammation defined by the implant-abutment interface. J Dent Res. 2006 May;85(5):473-8. doi: 10.1177/154405910608500515.
- Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.
- Peri-implant mucositis and peri-implantitis: a current understanding of their diagnoses and clinical implications. J Periodontol. 2013 Apr;84(4):436-43. doi: 10.1902/jop.2013.134001. No abstract available.
- Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
- Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.
- Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. doi: 10.1111/j.1600-0757.2005.00107.x. No abstract available.
- Klindworth A, Pruesse E, Schweer T, Peplies J, Quast C, Horn M, Glockner FO. Evaluation of general 16S ribosomal RNA gene PCR primers for classical and next-generation sequencing-based diversity studies. Nucleic Acids Res. 2013 Jan 7;41(1):e1. doi: 10.1093/nar/gks808. Epub 2012 Aug 28.
- Mombelli A, Marxer M, Gaberthuel T, Grunder U, Lang NP. The microbiota of osseointegrated implants in patients with a history of periodontal disease. J Clin Periodontol. 1995 Feb;22(2):124-30. doi: 10.1111/j.1600-051x.1995.tb00123.x.
- Sachdeo A, Haffajee AD, Socransky SS. Biofilms in the edentulous oral cavity. J Prosthodont. 2008 Jul;17(5):348-56. doi: 10.1111/j.1532-849X.2008.00301.x.
- Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x.
- Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.
- Shibli JA, Melo L, Ferrari DS, Figueiredo LC, Faveri M, Feres M. Composition of supra- and subgingival biofilm of subjects with healthy and diseased implants. Clin Oral Implants Res. 2008 Oct;19(10):975-82. doi: 10.1111/j.1600-0501.2008.01566.x.
- Zitzmann NU, Berglundh T. Definition and prevalence of peri-implant diseases. J Clin Periodontol. 2008 Sep;35(8 Suppl):286-91. doi: 10.1111/j.1600-051X.2008.01274.x.
- Tomasi C, Derks J. Clinical research of peri-implant diseases--quality of reporting, case definitions and methods to study incidence, prevalence and risk factors of peri-implant diseases. J Clin Periodontol. 2012 Feb;39 Suppl 12:207-23. doi: 10.1111/j.1600-051X.2011.01831.x.
- Tarica DY, Alvarado VM, Truong ST. Survey of United States dental schools on cementation protocols for implant crown restorations. J Prosthet Dent. 2010 Feb;103(2):68-79. doi: 10.1016/S0022-3913(10)00016-8.
- Moraguez OD, Belser UC. The use of polytetrafluoroethylene tape for the management of screw access channels in implant-supported prostheses. J Prosthet Dent. 2010 Mar;103(3):189-91. doi: 10.1016/S0022-3913(10)60029-7.
- Daubert DM, Weinstein BF, Bordin S, Leroux BG, Flemming TF. Prevalence and predictive factors for peri-implant disease and implant failure: a cross-sectional analysis. J Periodontol. 2015 Mar;86(3):337-47. doi: 10.1902/jop.2014.140438. Epub 2014 Nov 21.
- Mombelli A, Decaillet F. The characteristics of biofilms in peri-implant disease. J Clin Periodontol. 2011 Mar;38 Suppl 11:203-13. doi: 10.1111/j.1600-051X.2010.01666.x.
- Mombelli A, Buser D, Lang NP. Colonization of osseointegrated titanium implants in edentulous patients. Early results. Oral Microbiol Immunol. 1988 Sep;3(3):113-20. doi: 10.1111/j.1399-302x.1988.tb00095.x. No abstract available.
- Mombelli A, Mericske-Stern R. Microbiological features of stable osseointegrated implants used as abutments for overdentures. Clin Oral Implants Res. 1990 Dec;1(1):1-7. doi: 10.1034/j.1600-0501.1990.010101.x.
- Adell R, Lekholm U, Rockler B, Branemark PI, Lindhe J, Eriksson B, Sbordone L. Marginal tissue reactions at osseointegrated titanium fixtures (I). A 3-year longitudinal prospective study. Int J Oral Maxillofac Surg. 1986 Feb;15(1):39-52. doi: 10.1016/s0300-9785(86)80010-2.
- Kumar PS, Mason MR, Brooker MR, O'Brien K. Pyrosequencing reveals unique microbial signatures associated with healthy and failing dental implants. J Clin Periodontol. 2012 May;39(5):425-33. doi: 10.1111/j.1600-051X.2012.01856.x. Epub 2012 Mar 14.
- Danser MM, van Winkelhoff AJ, van der Velden U. Periodontal bacteria colonizing oral mucous membranes in edentulous patients wearing dental implants. J Periodontol. 1997 Mar;68(3):209-16. doi: 10.1902/jop.1997.68.3.209.
- Pontoriero R, Tonelli MP, Carnevale G, Mombelli A, Nyman SR, Lang NP. Experimentally induced peri-implant mucositis. A clinical study in humans. Clin Oral Implants Res. 1994 Dec;5(4):254-9. doi: 10.1034/j.1600-0501.1994.050409.x.
- Rutar A, Lang NP, Buser D, Burgin W, Mombelli A. Retrospective assessment of clinical and microbiological factors affecting periimplant tissue conditions. Clin Oral Implants Res. 2001 Jun;12(3):189-95. doi: 10.1034/j.1600-0501.2001.012003189.x.
- Salcetti JM, Moriarty JD, Cooper LF, Smith FW, Collins JG, Socransky SS, Offenbacher S. The clinical, microbial, and host response characteristics of the failing implant. Int J Oral Maxillofac Implants. 1997 Jan-Feb;12(1):32-42.
- Persson GR, Renvert S. Cluster of bacteria associated with peri-implantitis. Clin Implant Dent Relat Res. 2014 Dec;16(6):783-93. doi: 10.1111/cid.12052. Epub 2013 Mar 25.
- Albertini M, Lopez-Cerero L, O'Sullivan MG, Chereguini CF, Ballesta S, Rios V, Herrero-Climent M, Bullon P. Assessment of periodontal and opportunistic flora in patients with peri-implantitis. Clin Oral Implants Res. 2015 Aug;26(8):937-941. doi: 10.1111/clr.12387. Epub 2014 Apr 10.
- Salvi GE, Aglietta M, Eick S, Sculean A, Lang NP, Ramseier CA. Reversibility of experimental peri-implant mucositis compared with experimental gingivitis in humans. Clin Oral Implants Res. 2012 Feb;23(2):182-190. doi: 10.1111/j.1600-0501.2011.02220.x. Epub 2011 Aug 2.
- Charalampakis G, Leonhardt A, Rabe P, Dahlen G. Clinical and microbiological characteristics of peri-implantitis cases: a retrospective multicentre study. Clin Oral Implants Res. 2012 Sep;23(9):1045-54. doi: 10.1111/j.1600-0501.2011.02258.x. Epub 2011 Aug 3.
- Quirynen M, van Steenberghe D. Bacterial colonization of the internal part of two-stage implants. An in vivo study. Clin Oral Implants Res. 1993 Sep;4(3):158-61. doi: 10.1034/j.1600-0501.1993.040307.x.
- Passos SP, Gressler May L, Faria R, Ozcan M, Bottino MA. Implant-abutment gap versus microbial colonization: Clinical significance based on a literature review. J Biomed Mater Res B Appl Biomater. 2013 Oct;101(7):1321-8. doi: 10.1002/jbm.b.32945. Epub 2013 May 10.
- Persson LG, Lekholm U, Leonhardt A, Dahlen G, Lindhe J. Bacterial colonization on internal surfaces of Branemark system implant components. Clin Oral Implants Res. 1996 Jun;7(2):90-5. doi: 10.1034/j.1600-0501.1996.070201.x.
- Nascimento Cd, Ikeda LN, Pita MS, Pedroso e Silva RC, Pedrazzi V, Albuquerque RF, Ribeiro RF. Marginal fit and microbial leakage along the implant-abutment interface of fixed partial prostheses: An in vitro analysis using Checkerboard DNA-DNA hybridization. J Prosthet Dent. 2015 Dec;114(6):831-8. doi: 10.1016/j.prosdent.2015.05.009. Epub 2015 Sep 8.
- Gross M, Abramovich I, Weiss EI. Microleakage at the abutment-implant interface of osseointegrated implants: a comparative study. Int J Oral Maxillofac Implants. 1999 Jan-Feb;14(1):94-100.
- Covani U, Marconcini S, Crespi R, Barone A. Bacterial plaque colonization around dental implant surfaces. Implant Dent. 2006 Sep;15(3):298-304. doi: 10.1097/01.id.0000226823.58425.19.
- da Silva-Neto JP, Nobilo MA, Penatti MP, Simamoto PC Jr, das Neves FD. Influence of methodologic aspects on the results of implant-abutment interface microleakage tests: a critical review of in vitro studies. Int J Oral Maxillofac Implants. 2012 Jul-Aug;27(4):793-800.
- Taylor RC, Ghoneim AS, McGlumphy EA. An esthetic technique to fill screw-retained fixed prostheses. J Oral Implantol. 2004;30(6):384-5. doi: 10.1563/0681.1.
- Park SD, Lee Y, Kim YL, Yu SH, Bae JM, Cho HW. Microleakage of different sealing materials in access holes of internal connection implant systems. J Prosthet Dent. 2012 Sep;108(3):173-80. doi: 10.1016/S0022-3913(12)60143-7.
- da Silva ES, Feres M, Figueiredo LC, Shibli JA, Ramiro FS, Faveri M. Microbiological diversity of peri-implantitis biofilm by Sanger sequencing. Clin Oral Implants Res. 2014 Oct;25(10):1192-9. doi: 10.1111/clr.12231. Epub 2013 Jul 12.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2013
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
29. november 2015
Først indsendt, der opfyldte QC-kriterier
7. december 2015
Først opslået (Skøn)
9. december 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 409069
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .