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The Impact of Material on Microbiota in Association With Tongue and Lip Piercing

This study has been completed.
Sponsor:
Collaborator:
Austrian Society of Periodontology
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01039259
First received: December 23, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

December 23, 2009
December 23, 2009
August 2008
February 2009   (final data collection date for primary outcome measure)
microbiologic findings of piercing samples [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Impact of Material on Microbiota in Association With Tongue and Lip Piercing
Not Provided

Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota.

The investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. The investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations.

85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. Sterile piercings of four different materials will be randomly allocated to the study subjects. After two weeks, microbiologic samples are collected and are processed by checkerboard DNA-DNA hybridization methods.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

85 subjects with lip piercing 85 subjects with tongue piercing

Bacteremia
Device: piercings of four different materials
randomly assigned sterile piercings are inserted for two weeks
Other Names:
  • piercing materials:
  • steel, titanium, polypropylene, polytetrafluoroethylene
  • subjects with lip piercing
    Intervention: Device: piercings of four different materials
  • subjects with tongue piercing
    Intervention: Device: piercings of four different materials
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • lip/tongue piercing for at least six month in situ

Exclusion Criteria:

  • pregnancy and lactating women
  • medication with known effects on gingival tissues
  • antibiotic medication in the last six months or need for antibiotic prophylaxis
  • chlorhexidine use in the last six months
  • non-plaque induced gingival disease
  • prior diagnosis of periodontitis
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01039259
AN3223 265/4.7
Not Provided
Ines Kapferer, Dr., Innsbruck Medical University
Medical University Innsbruck
Austrian Society of Periodontology
Principal Investigator: Ines Kapferer, Dr. Innsbruck Medical University
Medical University Innsbruck
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP