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

December 23, 2009 updated by: Medical University Innsbruck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Innsbruck Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

85 subjects with lip piercing 85 subjects with tongue piercing

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
microbiologic findings of piercing samples
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Collaborators

Austrian Society of Periodontology

Investigators

  • Principal Investigator: Ines Kapferer, Dr., Innsbruck Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (ESTIMATE)

December 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN3223 265/4.7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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