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A Comparison of Inflammatory Mediators Surrounding Titanium or Zirconium Implant Abutments

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ClinicalTrials.gov Identifier: NCT01870349
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
Dentsply Sirona Implants
University of Iowa Institute for Clinical and Translational Science
Information provided by (Responsible Party):
Christopher Barwacz, University of Iowa

Tracking Information
First Submitted Date May 30, 2013
First Posted Date June 6, 2013
Last Update Posted Date February 27, 2018
Study Start Date December 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2018)
Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments [ Time Frame: At least 6 months post crown placement ]
Levels of pro-inflammatory and bone mediators
Original Primary Outcome Measures
 (submitted: June 3, 2013)
Levels of pro-inflammatory and bone mediators (pg/30 seconds) surrounding titanium vs. zirconium abutments [ Time Frame: At least 6 months post crown placement ]
Change History Complete list of historical versions of study NCT01870349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparison of Inflammatory Mediators Surrounding Titanium or Zirconium Implant Abutments
Official Title Evaluation of Pro-inflammatory Mediators Around Astra Tech Dental Implant Abutments Following a Minimum of 6 Months of Clinical Function
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.
Detailed Description

The aim of this cross-sectional study is to utilize the paper strip-based peri-implant crevicular fluid (PICF) sampling technique to evaluate the influence that transmucosal abutment biomaterials of either titanium or zirconium oxide, which have been in situ for greater than six months, have in the expression of specific pro-inflammatory and bone-mediators.

Subjects who had previously undergone single-tooth implant replacement therapy are invited to participate and informed consent is obtained.

All participants receive a clinical and radiographic exam of the implant site that is sampled for PICF. Clinical and radiographic parameters such as implant mobility, presence or absence of supragingival plaque, and interproximal bone levels were assessed. Peri-apical radiographs, utilizing a paralleling technique, will be obtained from each implant fixture to evaluate the marginal bone level compared to baseline periapical radiographs made at the time of definitive prosthesis delivery. Each participant's implant site is isolated with cotton rolls, light air is applied over the site to eliminate the potential for ambient salivary contamination of the PICF sample. The implant site is sampled for 30 seconds at four distinct sites (mesio-buccal, disto-buccal, mesio-lingual, disto-lingual) by one clinician under loupe magnification. The fluid volumes collected on each strip will be quantified using the Periotron 8000 Instrument.

Cytokine, chemokine, and bone mediator quantities (pg/30 s) were determined using a commercial 22-multiplexed fluorescent bead-based immunoassay. Two specific multiplex kits are utilized (Milliplex MAP Human cytokine/Chemokine Immunoassay & Milliplex MAP Human Bone Panel 1B Immunoassay).

Biostatisticians are masked to the implant abutment biomaterial designations (masked as "A" and "B") during data analysis. Initial bivariate analysis using the Wilcoxon-Mann-Whitney (Wilcoxon Rank Sum) test will be employed to assess the difference in distribution between the two groups (titanium dioxide or zirconium oxide) for each cytokine/bone mediator and for age. The same approach is used to consider whether a gender difference was associated with a particular cytokine/bone mediator. Gender distribution in the two groups will be compared using the Fisher exact test. The Spearman rank correlation will be used to assess the possibility of a relationship with age for each cytokine. Rank-based regression models will be used to adjust for possible effects of age and gender for both cytokine and bone mediator levels.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Gingival crevicular fluids
Sampling Method Non-Probability Sample
Study Population Community sample, dental clinic patients
Condition Peri-implantitis
Intervention Procedure: Gingival Crevicular Fluid Sampling
Gingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months
Study Groups/Cohorts
  • Titanium Implant Abutments
    Gingival Crevicular Fluid Sampling
    Intervention: Procedure: Gingival Crevicular Fluid Sampling
  • Zirconium Implant Abutments
    Gingival Crevicular Fluid Sampling
    Intervention: Procedure: Gingival Crevicular Fluid Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2013)
46
Original Actual Enrollment Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria::

  • 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.

Exclusion Criteria:

  • subjects who are pregnant
  • immunosuppressed subjects
  • diabetes
  • smokers
  • alcohol or drug abuse
  • systemic anti-inflammatory medication use
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01870349
Other Study ID Numbers 200911729
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Barwacz, University of Iowa
Study Sponsor Christopher Barwacz
Collaborators
  • Dentsply Sirona Implants
  • University of Iowa Institute for Clinical and Translational Science
Investigators
Principal Investigator: Chris A Barwacz, DDS University of Iowa
PRS Account University of Iowa
Verification Date February 2018