Skip to main content
OpenTrials
Completed

NCT Number: NCT01870349

A Comparison of Inflammatory Mediators Surrounding Titanium or Zirconium Implant Abutments

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gingival Crevicular Fluid Sampling

Procedure

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Christopher Barwacz

Other

Collaborators

  • Dentsply Sirona Implants and Consumables
  • University of Iowa

Registry information

Official study title

Evaluation of Pro-inflammatory Mediators Around Astra Tech Dental Implant Abutments Following a Minimum of 6 Months of Clinical Function

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2013
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.