Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07196618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bond Strength Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004121', 'term': 'Dimethyl Sulfoxide'}], 'ancestors': [{'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-09-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical assessment evaluation using the FDI world dental federation criteria', 'timeFrame': 'post operative 2 weeks'}], 'secondaryOutcomes': [{'measure': 'clinical assessment evaluation using the FDI world dental federation criteria', 'timeFrame': 'post operative 3 months and 6 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bonding']}, 'descriptionModule': {'briefSummary': 'This study was evaluated the effect of dimethyl sulfoxide pretreatment on tensile bond strength and nanoleakage of resin composite bonded to aged dentin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in the study will be required to present at least one of non caries cervical lesion with sclerotic dentin without pulpal involvement.\n* Age of patient: 50 - 75 years\n* Patients with non caries cervical lesion will be standardized by clinical performance (FDI world dental federation).\n\nExclusion Criteria:\n\n* Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling\n* Developmental disorders and adjacent soft tissue lesions\n* Patients with systemic illness will be excluded.'}, 'identificationModule': {'nctId': 'NCT07196618', 'acronym': 'DMSO', 'briefTitle': 'Bond Strength Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Effect of Dimethyl Sulfoxide Pretreatment on Tensile Bond Strength and Nanoleakage of Resin Composite Bonded to Aged Dentin', 'orgStudyIdInfo': {'id': 'P-OP-23-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DMSO', 'interventionNames': ['Drug: dimethyl sulfoxide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CHX', 'interventionNames': ['Drug: Cholorhexidine']}], 'interventions': [{'name': 'dimethyl sulfoxide', 'type': 'DRUG', 'description': 'dentin pretreated using dimethyl sulfoxide and follow up of patients at 2 weeks, 3 months and 6 months', 'armGroupLabels': ['DMSO']}, {'name': 'Cholorhexidine', 'type': 'DRUG', 'description': 'dentin pretreated using chlorhexidine and follow up of patients at 2 weeks, 3months and 6 months', 'armGroupLabels': ['CHX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al-Azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Aisha Zahran', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aisha Nasr Ali Zahran', 'investigatorAffiliation': 'Al-Azhar University'}}}}