A Comparison of Inflammatory Mediators Surrounding Titanium or Zirconium Implant Abutments
Condition: Peri-implantitis
MeSH terms: Peri-Implantitis
Study type: Observational

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.
    

Intervention name(s): Gingival Crevicular Fluid Sampling
Intervention type(s): Procedure
Intervention description(s): Gingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample, dental clinic patients
      
Biospecimen description: 
      Gingival crevicular fluids
    
Keywords: cytokines; dental implants; peri-implantitis