Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-03 @ 1:47 PM
Study NCT ID:
NCT00643461
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of the restoration.', 'timeFrame': '6, 12, 24, 36 months post-placement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Class V cavities', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 19 years of age\n* Must have at least 3 qualifying noncarious Class V lesions of appropriate depth\n* Must be willing to sign consent form\n* Must be willing and able to return to UAB clinic for 4 study appointments\n* Must be in good medical health and able to tolerate dental procedures\n\nExclusion Criteria:\n\n* Current participation in other restorative product studies\n* Severe salivary gland dysfunction\n* Rampant caries (cavities)\n* Chronic periodontitis (gum disease)\n* Known allergies to the study materials\n* Unacceptable level of oral hygiene\n* Inability or unwillingness to attend study appointments'}, 'identificationModule': {'nctId': 'NCT00643461', 'briefTitle': 'Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations', 'orgStudyIdInfo': {'id': 'CR-07-009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adhesive A', 'interventionNames': ['Device: Adhesive A']}, {'label': 'Adhesive B', 'interventionNames': ['Device: Adhesive B']}, {'label': 'Adhesive C', 'interventionNames': ['Device: Adhesive C']}], 'interventions': [{'name': 'Adhesive A', 'type': 'DEVICE', 'otherNames': ['Adper Scotchbond SE (3M ESPE)'], 'description': "Applied per manufacturer's instructions.", 'armGroupLabels': ['Adhesive A']}, {'name': 'Adhesive B', 'type': 'DEVICE', 'otherNames': ['Adper Easy Bond (3M ESPE)'], 'description': "Applied per manufacturer's instructions.", 'armGroupLabels': ['Adhesive B']}, {'name': 'Adhesive C', 'type': 'DEVICE', 'otherNames': ['Single Bond Plus (3M ESPE)'], 'description': "Applied per manufacturer's instructions.", 'armGroupLabels': ['Adhesive C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB) School of Dentistry', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'John O Burgess, MS, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham (UAB) School of Dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}