BacteremiaNCT01039259
The Impact of Material on Microbiota in Association With Tongue and Lip Piercing
An observational study of Bacteremia, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacteremia
- What is being tested?
- piercings of four different materials
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 85 subjects with lip piercing 85 subjects with tongue piercing
Who may be able to join
- lip/tongue piercing for at least six month in situ
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- piercings of four different materials
- Keywords
- adolescent, body piercing/adverse effects, tongue piercing, tongue/microbiology
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piercings of four different materialsDevice
Also called piercing materials:, steel, titanium, polypropylene, polytetrafluoroethylene
randomly assigned sterile piercings are inserted for two weeks
| Study group | Role | What they receive |
|---|---|---|
| subjects with lip piercing | Not described Receives: Device: piercings of four different materials | |
| subjects with tongue piercing | Not described Receives: Device: piercings of four different materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiologic findings of piercing samples
Measured: 2 weeks
Secondary outcomes (1)
microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Society of Periodontology
- Investigators
- Ines Kapferer, Dr., Principal investigator, Innsbruck Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039259
- Sponsor's protocol ID
- AN3223 265/4.7
- Status last verified
- Jan 2009
- First submitted
- 23 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Material on Microbiota in Association With Tongue and Lip Piercing
- ClinicalTrials.gov ID
- NCT01039259
- Acronym / sponsor ID
- AN3223 265/4.7
- Conditions
- Bacteremia
- Keywords
- adolescent, body piercing/adverse effects, tongue piercing, tongue/microbiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Austrian Society of Periodontology
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with lip piercing | – | Device: piercings of four different materials |
| subjects with tongue piercing | – | Device: piercings of four different materials |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 85 subjects with lip piercing 85 subjects with tongue piercing
Key inclusion criteria (1 listed)
- lip/tongue piercing for at least six month in situ
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piercings of four different materialsAlso: piercing materials:, steel, titanium, polypropylene, polytetrafluoroethylenerandomly assigned sterile piercings are inserted for two weeks | Device | subjects with lip piercing, subjects with tongue piercing |
Primary outcome
microbiologic findings of piercing samples
Time frame: 2 weeks
1 secondary outcome
microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Kapferer, Dr. principal investigator
Innsbruck Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiologic findings of piercing samples (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.