Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 8:47 PM
Study NCT ID:
NCT00681135
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-21', 'studyFirstSubmitDate': '2008-05-16', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Indices', 'timeFrame': 'every 4 weeks for 3 months'}, {'measure': 'Gingival Indices', 'timeFrame': 'every 4 weeks for 3 months'}], 'secondaryOutcomes': [{'measure': 'Periodontal parameters', 'timeFrame': 'every 4 weeks'}, {'measure': 'Microbiological parameters', 'timeFrame': 'every 4 weeks'}, {'measure': 'Molecularbiological parameters', 'timeFrame': 'every 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orthodontics', 'toothbrush', 'interdental brush', 'oral hygiene'], 'conditions': ['Dental Plaque', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of a sonic toothbrush alone is more effective than two other toothbrushing protocols on dental plaque elimination in patients with fixed orthodontic appliances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no systemic diseases\n* orthodontic appliance (min. 10 completely erupted permanent teeth with brackets/bands)\n* informed consent\n\nExclusion Criteria:\n\n* presence of caries lesion\n* antibiotic therapy within the previous 6 months\n* diagnosis of early onset periodontitis'}, 'identificationModule': {'nctId': 'NCT00681135', 'briefTitle': 'Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Mechanical Plaque Control and Gingivitis Reduction in Fixed Appliance Patients: Comparison of Different Toothbrushing Protocols', 'orgStudyIdInfo': {'id': 'ZKL-08-MHW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Device: manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Device: manual toothbrush (elmex® Inter X medium toothbrush)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Device: manual toothbrush (elmex® Inter X medium toothbrush)']}], 'interventions': [{'name': 'sonic toothbrush (Philips Sonicare® FlexCare, Typ HX6942/04)', 'type': 'DEVICE', 'otherNames': ['Philips Sonicare® FlexCare'], 'description': 'toothbrushing with a sonic toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets', 'armGroupLabels': ['1']}, {'name': 'manual toothbrush / interdental toothbrush (elmex® Inter X medium toothbrush / interdental brush Curaprox®)', 'type': 'DEVICE', 'otherNames': ['elmex® Inter X medium toothbrush / interdental brush Curaprox®'], 'description': 'toothbrushing with a manual toothbrush and interdental brush and sealant coating (ProSeal™) of the enemal surface around the brackets', 'armGroupLabels': ['2']}, {'name': 'manual toothbrush (elmex® Inter X medium toothbrush)', 'type': 'DEVICE', 'otherNames': ['elmex® Inter X medium toothbrush'], 'description': 'toothbrushing with a manual toothbrush and sealant coating (ProSeal™) of the enemal surface around the brackets', 'armGroupLabels': ['3']}, {'name': 'manual toothbrush (elmex® Inter X medium toothbrush)', 'type': 'DEVICE', 'otherNames': ['elmex® Inter X medium toothbrush'], 'description': 'toothbrushing with a manual toothbrush without sealant coating of the enemal surface around the brackets', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of Orthodontics', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Christopher J. Lux, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Orthodontics, University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sebastian Zingler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. med. dent. Sebastian Zingler', 'investigatorFullName': 'Sebastian Zingler', 'investigatorAffiliation': 'University of Jena'}}}}