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Trial record 76 of 119 for:    ZIRCONIUM

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

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.

Condition or disease Intervention/treatment
Peri-implantitis Procedure: Gingival Crevicular Fluid Sampling

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.


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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Pro-inflammatory Mediators Around Astra Tech Dental Implant Abutments Following a Minimum of 6 Months of Clinical Function
Study Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Group/Cohort Intervention/treatment
Titanium Implant Abutments
Gingival Crevicular Fluid Sampling
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

Zirconium Implant Abutments
Gingival Crevicular Fluid Sampling
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




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Gingival crevicular fluids


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample, dental clinic patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870349


Locations
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United States, Iowa
University of Iowa College of Dentistry
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Christopher Barwacz
Dentsply Sirona Implants
University of Iowa Institute for Clinical and Translational Science
Investigators
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Principal Investigator: Chris A Barwacz, DDS University of Iowa

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Responsible Party: Christopher Barwacz, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT01870349     History of Changes
Other Study ID Numbers: 200911729
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Keywords provided by Christopher Barwacz, University of Iowa:
cytokines
dental implants
peri-implantitis
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases