Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT01039259
Status:
COMPLETED
Last Update Posted:
2009-12-24
First Post:
2009-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Material on Microbiota in Association With Tongue and Lip Piercing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-23', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microbiologic findings of piercing samples', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth', 'timeFrame': '2 weeks'}]}, 'conditionsModule': {'keywords': ['adolescent', 'body piercing/adverse effects', 'tongue piercing', 'tongue/microbiology'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota.\n\nThe 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.\n\n85 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '85 subjects with lip piercing 85 subjects with tongue piercing', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lip/tongue piercing for at least six month in situ\n\nExclusion Criteria:\n\n* pregnancy and lactating women\n* medication with known effects on gingival tissues\n* antibiotic medication in the last six months or need for antibiotic prophylaxis\n* chlorhexidine use in the last six months\n* non-plaque induced gingival disease\n* prior diagnosis of periodontitis'}, 'identificationModule': {'nctId': 'NCT01039259', 'briefTitle': 'The Impact of Material on Microbiota in Association With Tongue and Lip Piercing', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'orgStudyIdInfo': {'id': 'AN3223 265/4.7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with lip piercing', 'interventionNames': ['Device: piercings of four different materials']}, {'label': 'subjects with tongue piercing', 'interventionNames': ['Device: piercings of four different materials']}], 'interventions': [{'name': 'piercings of four different materials', 'type': 'DEVICE', 'otherNames': ['piercing materials:', 'steel, titanium, polypropylene, polytetrafluoroethylene'], 'description': 'randomly assigned sterile piercings are inserted for two weeks', 'armGroupLabels': ['subjects with lip piercing', 'subjects with tongue piercing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Innsbruck Medical University', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Ines Kapferer, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innsbruck Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Austrian Society of Periodontology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Ines Kapferer, Dr.', 'oldOrganization': 'Innsbruck Medical University'}}}}