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

Bacteremia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039259
• Other study ID #: AN3223 265/4.7
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: December 23, 2009
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2009
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacteremia

Intervention

Device:
• piercings of four different materials
randomly assigned sterile piercings are inserted for two weeks

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck

Sponsors (2)

Lead Sponsor	Collaborator
Medical University Innsbruck	Austrian Society of Periodontology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiologic findings of piercing samples		2 weeks	No
Secondary	microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth		2 weeks	No