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

Sponsor
Stony Brook University (Other)
Overall Status
Completed
CT.gov ID
NCT02625597
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
19
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cotton Pellet
  • Device: Polytetrafluoroethylene Tape
  • Device: Synthetic Foam
  • Device: Polyvinylsiloxane
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
An In Vivo Assessment of the Effects of Using Different Implant Abutment Occluding Materials on Implant Microleakage and the Peri-Implant Microbiome
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dental Materials

Device: Cotton Pellet
Other Names:
  • Richmond Dental Bleached Cotton

    • Device: Polytetrafluoroethylene Tape
    Other Names:
  • Teflon
  • Merco M55 Thread Seal Tape

    • Device: Synthetic Foam
    Other Names:
  • Jordco Endoring Foam Inserts

    • Device: Polyvinylsiloxane
    Other Names:
  • Dentsply Aquasil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Probing Depth [6 months]

    Secondary Outcome Measures

    1. Gingival Index [6 Months]

    2. Plaque Index [6 Months]

    3. Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols [6 Months]

    4. Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols [6 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Dental Medicine of Stony Brook University Stony Brook New York United States 11794

    Sponsors and Collaborators

    • Stony Brook University

    Investigators

    • Principal Investigator: Julio A Carrion, DMD, PhD, Stony Brook University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Julio Carrion, Assistant Professor, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT02625597
    Other Study ID Numbers:
    • 409069
    First Posted:
    Dec 9, 2015
    Last Update Posted:
    Dec 9, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Peri-Implantitis

    Study Results

    No Results Posted as of Dec 9, 2015