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Peri-ImplantitisNCT02625597

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

A study testing Cotton Pellet, Polytetrafluoroethylene Tape and Synthetic Foam in people with Peri-Implantitis and Dental Implant Failed, run by Stony Brook University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Cotton Pellet, Polytetrafluoroethylene Tape and Synthetic Foam
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Nov 2013to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • School of Dental Medicine of Stony Brook University

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: 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.

Being tested
Cotton Pellet, Polytetrafluoroethylene Tape, Synthetic Foam, Polyvinylsiloxane
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cotton PelletDevice

    Also called Richmond Dental Bleached Cotton

  • Polytetrafluoroethylene TapeDevice

    Also called Teflon, Merco M55 Thread Seal Tape

  • Synthetic FoamDevice

    Also called Jordco Endoring Foam Inserts

  • PolyvinylsiloxaneDevice

    Also called Dentsply Aquasil

Study groups in NCT02625597
Study groupRoleWhat they receive
Dental MaterialsExperimentalNot described
Receives: Device: Cotton Pellet; Device: Polytetrafluoroethylene Tape; Device: Synthetic Foam; Device: Polyvinylsiloxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probing Depth

    Measured: 6 months

Secondary outcomes (4)

  1. Gingival Index

    Measured: 6 Months

  2. Plaque Index

    Measured: 6 Months

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

    Measured: 6 Months

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

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study startNov 2013
  3. Primary completionJan 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625597
Sponsor's protocol ID
409069
Status last verified
Dec 2015
First submitted
29 Nov 2015
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20141811

  • 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.

    PubMed 20188242

  • 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.

    PubMed 23537178

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

    PubMed 22754901

  • 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.

    PubMed 18724856

  • 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.

    PubMed 23237585

  • 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.

    PubMed 25415249

  • 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.

    PubMed 22533958

  • 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.

    PubMed 21323716

  • 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.

    PubMed 3269993

  • 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.

    PubMed 2099207

  • 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.

    PubMed 3083005

  • 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.

    PubMed 18828812

  • 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.

    PubMed 22417294

  • 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.

    PubMed 9100195

Questions about this trial

What is this clinical trial studying?

A study testing Cotton Pellet, Polytetrafluoroethylene Tape and Synthetic Foam in people with Peri-Implantitis and Dental Implant Failed, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probing Depth (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625597, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.

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