The Impact of Material on Microbiota in Association With... | NCT01039259

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

NCT01039259

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Dec 24, 2009Estimated

Enrollment

170

Phase

Not provided

Conditions

Bacteremia

Interventions

piercings of four different materials

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2009

Last Update Posted Date

Dec 24, 2009Estimated

Name	Class
Austrian Society of Periodontology	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subjects with lip piercing			Device: piercings of four different materials
subjects with tongue piercing			Device: piercings of four different materials

Interventions

Name	Type	Description	Arm Group Labels	Other Names
piercings of four different materials	Device	randomly assigned sterile piercings are inserted for two weeks	subjects with lip piercing subjects with tongue piercing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microbiologic findings of piercing samples		2 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

85 subjects with lip piercing 85 subjects with tongue piercing

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ines Kapferer, Dr.	Innsbruck Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innsbruck Medical University		Innsbruck		6020	Austria

Condition Browse Module

MeSH Terms

ID	Term
D016470	Bacteremia

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis

Browse Leaves

Not provided

Browse Branches

Not provided