Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-08 @ 12:31 AM
Study NCT ID:
NCT05161559
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003763', 'term': 'Dental Leakage'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage % of patients with marginal staining', 'timeFrame': '3 years after restoration procedure', 'description': 'Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resin Composite', 'Randomized Clinical Trial', 'Operative Dentistry'], 'conditions': ['Dental Leakage']}, 'descriptionModule': {'briefSummary': 'This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.', 'detailedDescription': 'The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.\n\nThe research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3.\n2. Patients with normal and full occlusion.\n3. Patients with tooth gives positive response to testing with an electric pulp tester.\n4. Patients must have a good oral hygiene.\n5. Patients with opposing teeth should be natural with no restorations.\n\nExclusion Criteria:\n\n1. High caries risk patients with extremely poor oral hygiene.\n2. Patients involved in orthodontic treatment or periodontal surgery.\n3. Patients with periodontally involved teeth (chronic periodontitis).\n4. Patients with heavy bruxism habits and clenching.\n5. Patients with abutments should be excluded.'}, 'identificationModule': {'nctId': 'NCT05161559', 'briefTitle': 'Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Adhesive Performance of Glass Ionomer Versus Resin Based Adhesive Systems', 'orgStudyIdInfo': {'id': 'A12151221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fuji Bond LC (Glass ionomer based adhesive)', 'description': 'Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth', 'interventionNames': ['Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)']}, {'type': 'EXPERIMENTAL', 'label': 'Riva Bond LC (Glass ionomer based adhesive)', 'description': 'Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth', 'interventionNames': ['Procedure: Chemical bond adhesive (GC, Corporation, Tokyo, Japan)']}, {'type': 'EXPERIMENTAL', 'label': 'Single Bond Universal (self-etch adhesive)', 'description': 'Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth', 'interventionNames': ['Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)']}, {'type': 'EXPERIMENTAL', 'label': 'Clearfill S3 Bond (self-etch adhesive)', 'description': 'Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth', 'interventionNames': ['Procedure: Self-etch adhesive (Kuraray, Tokyo, Japan)']}, {'type': 'EXPERIMENTAL', 'label': 'OptiBond FL (three step etch & rinse adhesive)', 'description': 'Patients received in Class V cavity preparation OptiBond FL (three step etch \\& rinse adhesive) on one tooth of the mouth', 'interventionNames': ['Procedure: Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)']}], 'interventions': [{'name': 'Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)', 'type': 'PROCEDURE', 'description': 'Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)', 'armGroupLabels': ['OptiBond FL (three step etch & rinse adhesive)']}, {'name': 'Self-etch adhesive (Kuraray, Tokyo, Japan)', 'type': 'PROCEDURE', 'description': 'No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)', 'armGroupLabels': ['Clearfill S3 Bond (self-etch adhesive)', 'Single Bond Universal (self-etch adhesive)']}, {'name': 'Chemical bond adhesive (GC, Corporation, Tokyo, Japan)', 'type': 'PROCEDURE', 'description': 'Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)', 'armGroupLabels': ['Fuji Bond LC (Glass ionomer based adhesive)', 'Riva Bond LC (Glass ionomer based adhesive)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available within 3 Months for 5 years', 'ipdSharing': 'YES', 'description': 'study Protocol, Statistical Analysis Plan can be shared to other researchers', 'accessCriteria': 'For anyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}