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

December 7, 2015 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • School of Dental Medicine of Stony Brook University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probing Depth
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Gingival Index
Time Frame: 6 Months
6 Months
Plaque Index
Time Frame: 6 Months
6 Months
Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols
Time Frame: 6 Months
6 Months
Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 409069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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