Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-26 @ 9:15 PM
Study NCT ID:
NCT04657757
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The test persons are numbered so that the laboratory technician who performs the analysis of the platelets cannot be assigned a name. Blinding with regard to the materials is not possible, as the color differences of the alloys allow for a classification.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quantification of biofilm', 'timeFrame': '2x 24hours in a period of about 10 days', 'description': 'quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).'}], 'secondaryOutcomes': [{'measure': 'number of CFU', 'timeFrame': '2x 24hours in a period of about 10 days', 'description': 'Possible bactericidal effects of the materials, which are analyzed by CFU determination, serve as secondary target parameter.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intraoral biofilm formation', 'parodontitis', 'tooth implant', 'periimplant diseases'], 'conditions': ['Dental Diseases']}, 'descriptionModule': {'briefSummary': 'Investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials', 'detailedDescription': 'The aim of this study is to investigate bacterial attachment and bactericidal effects of different materials used for the transmucosal part of implants. Using a brace, the intraoral biofilm formation in healthy subjects will be measured after 28 hours (24 hours intraorally, 4 hours rest). For this purpose 2 sterile platelets of each of the 8 differently processed materials (16 platelets in total) are inserted into the braces.\n\nThe main target parameter is the quantification of the biofilm by crystal violet staining. For this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (OD595).\n\nAs secondary target parameter possible bactericidal effects of the materials, which are analyzed by Colony forming units (CFU) determination, are used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No systemic antibiotic therapy during the last 3 months\n* Good oral hygiene and compliance (plaque index (PI) \\<20%, bleeding index (BI) \\<20%)\n* No signs of periodontitis or other inflammatory changes in surrounding tissues\n* Non-smokers\n\nExclusion Criteria:\n\n* Disease that requires antibiotics\n* Pressure points caused by the braces, which cannot be eliminated by adjusting\n* Other unforeseen complications that can be associated with braces'}, 'identificationModule': {'nctId': 'NCT04657757', 'briefTitle': 'Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Investigation of Bacterial Adhesion and Bactericide Effect ex Vivo on Different Implant Restoration Materials', 'orgStudyIdInfo': {'id': '2018-00248; sp20Zeller'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoral apparatus', 'description': 'intraoral apparatus in which two platelets of each of the 8 materials (Esteticor Lumina PF; Esteticor Lumina PF - after Lactic acid storage; Pagalinor 2; Esteticor Economic; Pekkton ivory - untreated; Pekkton ivory - rough; Oralloy; Machined Titan Zirconia (TiZr) alloy) are to be examined. Examination is a crystal violet OD595 staining (10 minutes). The color absorbed by the bacteria is then dissolved with a 30% acetic acid and measured spectrophotometrically at 595 nm. The plaque formed on the material surface is removed immediately after removal from the oral cavity and analyzed by determination of Colony Forming Unit (CFU) number.', 'interventionNames': ['Other: Intraoral apparatus']}], 'interventions': [{'name': 'Intraoral apparatus', 'type': 'OTHER', 'description': 'Eight platelets with different material composition and surface properties are fastened in a holder (carrier rondell) with 15 mm diameter and inserted into the braces. Braces are to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures. Platelets then are removed and analyzed. After a first course the braces are to be cleaned in chlorhexidine solution in an ultrasonic bath; followed by a second identical course (Braces to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures).', 'armGroupLabels': ['Intraoral apparatus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Center for Dentistry Basel UZB', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Nicola Zitzmann, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Center for Dentistry Basel UZB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}