NCT01870349

Brief Summary

The purpose of this study is to determine whether there are differences in inflammatory markers and bone-mediator protein expression in the fluid surrounding implant abutments manufactured with either titanium or zirconium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

May 30, 2013

Last Update Submit

February 23, 2018

Conditions

Peri-implantitis

Keywords

cytokinesdental implantsperi-implantitis

Outcome Measures

Primary Outcomes (1)

  • Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments

    Levels of pro-inflammatory and bone mediators

    At least 6 months post crown placement

Study Arms (2)

Titanium Implant Abutments

Gingival Crevicular Fluid Sampling

Procedure: Gingival Crevicular Fluid Sampling

Zirconium Implant Abutments

Gingival Crevicular Fluid Sampling

Procedure: Gingival Crevicular Fluid Sampling

Interventions

Gingival Crevicular Fluid SamplingPROCEDURE

Gingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months

Titanium Implant AbutmentsZirconium Implant Abutments

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample, dental clinic patients

You may qualify if:

  • presence of a single-tooth implant-supported restoration bounded by natural teeth in stable occlusion
  • pre-fabricated or computer aided design and computer aided manufactured (CAD/CAM) transmucosal abutments of either commercially-pure titanium dioxide or zirconium dioxide
  • a minimum of 6 months of clinical function in situ.

You may not qualify if:

  • subjects who are pregnant
  • immunosuppressed subjects
  • diabetes
  • smokers
  • alcohol or drug abuse
  • systemic anti-inflammatory medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluids

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Chris A Barwacz, DDS

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 6, 2013

Study Start

December 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

US(1)