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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
  Purpose

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.


Condition Intervention
Bacteremia
Device: piercings of four different materials

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • microbiologic findings of piercing samples [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: August 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
subjects with lip piercing 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 tongue piercing Device: piercings of four different materials
randomly assigned sterile piercings are inserted for two weeks
Other Names:
  • piercing materials:
  • steel, titanium, polypropylene, polytetrafluoroethylene

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

85 subjects with lip piercing 85 subjects with tongue piercing

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039259

Locations
Austria
Innsbruck Medical University
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Austrian Society of Periodontology
Investigators
Principal Investigator: Ines Kapferer, Dr. Innsbruck Medical University
  More Information

No publications provided

Responsible Party: Ines Kapferer, Dr., Innsbruck Medical University
ClinicalTrials.gov Identifier: NCT01039259     History of Changes
Other Study ID Numbers: AN3223 265/4.7
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Medical University Innsbruck:
adolescent
body piercing/adverse effects
tongue piercing
tongue/microbiology

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014