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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cotton Pellet
Polytetrafluoroethylene Tape
Synthetic Foam
Polyvinylsiloxane
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-Implantitis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Dental Medicine of Stony Brook University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dental Materials

Arm Description

Outcomes

Primary Outcome Measures

Probing Depth

Secondary Outcome Measures

Gingival Index
Plaque Index
Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols
Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols

Full Information

First Posted
November 29, 2015
Last Updated
December 7, 2015
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT02625597
Brief Title
Assessment of the Effects of Different Implant Abutment Occluding Materials on Dental Implant Health Parameters and Microbiology
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Dental Implant Failed, Dental Implant Failure Nos

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental Materials
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cotton Pellet
Other Intervention Name(s)
Richmond Dental Bleached Cotton
Intervention Type
Device
Intervention Name(s)
Polytetrafluoroethylene Tape
Other Intervention Name(s)
Teflon, Merco M55 Thread Seal Tape
Intervention Type
Device
Intervention Name(s)
Synthetic Foam
Other Intervention Name(s)
Jordco Endoring Foam Inserts
Intervention Type
Device
Intervention Name(s)
Polyvinylsiloxane
Other Intervention Name(s)
Dentsply Aquasil
Primary Outcome Measure Information:
Title
Probing Depth
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gingival Index
Time Frame
6 Months
Title
Plaque Index
Time Frame
6 Months
Title
Microbial DNA Composition of the Peri-Implant Sulcus Assessed By PCR and Sequencing Protocols
Time Frame
6 Months
Title
Microbial DNA Composition on the Dental Materials Assessed By PCR and Sequencing Protocols
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio A Carrion, DMD, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dental Medicine of Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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

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