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

NCT01039259 | Completed

• 1 other identifier: AN3223 265/4.7
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacteremia

Keywords

adolescent; body piercing/adverse effects; tongue piercing; tongue/microbiology

Outcome Measures

Primary Outcomes (1)

• microbiologic findings of piercing samples

  2 weeks

Secondary Outcomes (1)

• microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth

  2 weeks

Study Arms (2)

subjects with lip piercing

Device: piercings of four different materials

subjects with tongue piercing

Device: piercings of four different materials

Interventions

piercings of four different materials DEVICE

randomly assigned sterile piercings are inserted for two weeks

Also known as: piercing materials:, steel, titanium, polypropylene, polytetrafluoroethylene

subjects with lip piercing; subjects with tongue piercing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

85 subjects with lip piercing 85 subjects with tongue piercing

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Austrian Society of Periodontology: collaborator

Study Sites (1)

Innsbruck Medical University

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ines Kapferer, Dr.

  Innsbruck Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 24, 2009
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 24, 2009

Record last verified: 2009-01

Locations

AU (1)