Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology

NCT02625597 | Completed

• 1 other identifier: 409069
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis; Dental Implant Failed; Dental Implant Failure Nos

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  6 months

Secondary Outcomes (4)

• Gingival Index

  6 Months

• Plaque Index

  6 Months

• Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols

  6 Months

• Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols

  6 Months

Study Arms (1)

Dental Materials

EXPERIMENTAL

Device: Cotton Pellet; Device: Polytetrafluoroethylene Tape; Device: Synthetic Foam; Device: Polyvinylsiloxane

Interventions

Cotton Pellet DEVICE

Also known as: Richmond Dental Bleached Cotton

Dental Materials

Polytetrafluoroethylene Tape DEVICE

Also known as: Teflon, Merco M55 Thread Seal Tape

Dental Materials

Synthetic Foam DEVICE

Also known as: Jordco Endoring Foam Inserts

Dental Materials

Polyvinylsiloxane DEVICE

Also known as: Dentsply Aquasil

Dental Materials

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully edentulous patient
• Patient has at least one arch restored with a full-arch dental supported prosthesis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

School of Dental Medicine of Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (40)

• 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.

  PMID: 20141811 BACKGROUND

• 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.

  PMID: 20188242 BACKGROUND

• 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.

  PMID: 23537178 BACKGROUND

• Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.

  PMID: 22754901 BACKGROUND

• 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.

  PMID: 18724856 BACKGROUND

• 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.

  PMID: 23237585 BACKGROUND

• 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.

  PMID: 25415249 BACKGROUND

• 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.

  PMID: 22533958 BACKGROUND

• 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.

  PMID: 21323716 BACKGROUND

• 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.

  PMID: 3269993 BACKGROUND

• 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.

  PMID: 2099207 BACKGROUND

• 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.

  PMID: 3083005 BACKGROUND

• 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.

  PMID: 18828812 BACKGROUND

• 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.

  PMID: 22417294 BACKGROUND

• 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.

  PMID: 9100195 BACKGROUND

• 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.

  PMID: 18355168 BACKGROUND

• 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.

  PMID: 7775668 BACKGROUND

• 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.

  PMID: 7640340 BACKGROUND

• 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.

  PMID: 3507627 BACKGROUND

• 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.

  PMID: 11359474 BACKGROUND

• 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.

  PMID: 9048452 BACKGROUND

• 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.

  PMID: 23527870 BACKGROUND

• 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.

  PMID: 24720498 BACKGROUND

• 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.

  PMID: 21806683 BACKGROUND

• 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.

  PMID: 18724855 BACKGROUND

• 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.

  PMID: 22092339 BACKGROUND

• 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.

  PMID: 8297964 BACKGROUND

• 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.

  PMID: 23661560 BACKGROUND

• 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.

  PMID: 9002826 BACKGROUND

• 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.

  PMID: 26359546 BACKGROUND

• 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.

  PMID: 10074758 BACKGROUND

• 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.

  PMID: 7790533 BACKGROUND

• 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.

  PMID: 16632764 BACKGROUND

• 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.

  PMID: 16966904 BACKGROUND

• 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.

  PMID: 22848880 BACKGROUND

• 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.

  PMID: 15641458 BACKGROUND

• 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.

  PMID: 22944313 BACKGROUND

• 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.

  PMID: 22933715 BACKGROUND

• 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.

  PMID: 15853940 BACKGROUND

• 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.

  PMID: 23845046 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Julio A Carrion, DMD, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 9, 2015
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (1)