Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT01369134
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-07', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of the Restoration', 'timeFrame': 'one year', 'description': 'Bonded filling still in place'}], 'secondaryOutcomes': [{'measure': 'Clinical performance of the study restoration', 'timeFrame': 'one year', 'description': 'Restoration in satisfactory clinical function at one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['self-etch adhesive', 'selective enamel etching', 'Adper Easy Bond', 'Supreme Ultra', 'Molar and premolar teeth', 'Adult', 'Class I and II cavities'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.', 'detailedDescription': 'There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dental patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* written informed consent\n* regular dental attender, can return to clinic for study recalls\n* good medical health\n* normal saliva flow\n* has one or two pairs of back teeth that require a Class I or II restoration of appropriate size\n* study teeth that are vital\n\nExclusion Criteria:\n\n* currently in an evaluation of other dental materials\n* an irregular dental attender\n* has unacceptable oral hygiene standards\n* has chronic periodontitis or rampant caries\n* has teeth with signs of periapical pathology\n* has history of pulp problems, and/or needs pulp treatment\n* women who are pregnant or breast-feeding\n* has known allergy to resin composite or latex\n* has serious chronic disease requiring hospitalization\n* has oral soft tissue pathologies\n* takes medications which, in the opinion of the investigator, could interfere with the conduct of the study\n* has current or recent history of alcohol or other substance abuse\n* is an employee of the sponsor or the study site, or members of their immediate family\n* has had any restorative treatment of teeth involved in the study in the last twelve months'}, 'identificationModule': {'nctId': 'NCT01369134', 'briefTitle': 'Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solventum US LLC'}, 'officialTitle': 'Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique', 'orgStudyIdInfo': {'id': 'CR-10-014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adper Easy Bond Self-etch dental adhesive', 'type': 'DEVICE', 'otherNames': ['self etch adhesive with enamel etch'], 'description': 'Bonding composite to restore Class I or Class II cavities'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'School of Dental Medicine', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Carlos Munoz, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solventum US LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}