Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05509127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2022-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000269', 'term': 'Adhesives'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Marginal adaptation', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months.', 'description': 'using Modified USPHS criteria'}], 'secondaryOutcomes': [{'measure': 'Marginal discoloration', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months.', 'description': 'using Modified USPHS criteria'}, {'measure': 'Post-operative sensitivity', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months.', 'description': 'using Modified USPHS criteria'}, {'measure': 'Retention', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months.', 'description': 'using Modified USPHS criteria'}, {'measure': 'Secondary caries', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months.', 'description': 'using Modified USPHS criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Performance', 'Carious', 'Cervical', 'Universal adhesive', 'USPHS criteria'], 'conditions': ['Clinical Performance']}, 'descriptionModule': {'briefSummary': 'Class V restorations are evaluated to reveal whether the use of modified universal adhesive will have a similar performance compared to conventional universal adhesive or not.', 'detailedDescription': 'The innovative Scotchbond Universal Plus Adhesive offers all the benefits of its predecessor, Single Bond Universal Adhesive as demonstrated by a 3M field evaluation comparing the performance of the two products. These benefits include:\n\n* Compatibility with all etching techniques - total-etch, self-etch, and selective enamel etch.\n* Usage with direct and indirect indications.\n* Bonding to all dental surfaces without the need for separate primers or silanes\n* Virtually no post-operative sensitivity.\n\nThe newly modified adhesive with its careful formulation offers:\n\n* Radiopacity like dentin to reduce the risk of X-ray misdiagnosis and overtreatment.\n* Ability to bond and seal caries-affected dentin to support minimally invasive preparation guidelines and maximize preservation of natural tooth structure.\n* Adhesion to all dental substrates and all direct and indirect materials, including glass ceramics.\n* Full dual- and self-cure compatibility without the need for an additional dual-cure activator bottle.\n* A BPA derivative-free formulation to alleviate concerns about BPA in dental materials\n* A fully aligned system with RelyX™ Universal Resin Cement, offering excellent bond strength for virtually all dual-cure resin cement indications.\n\nAs with any new material or technique, long-term clinical evaluations are needed to demonstrate the value of universal bonding agents adequately. So, the aim of this study is to evaluate the clinical performance of the modified universal adhesive, versus the conventional universal adhesive, for restoring carious class V cavities over one year and a half.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Small to moderate carious cervical lesions. (ICDAS scores 3,4)\n* Upper premolar teeth.\n* Good oral hygiene (mild to moderate plaque accumulation)\n* Vital teeth with no signs of irreversible pulpitis.\n* Presence of favorable occlusion and normal contact with adjacent teeth.\n\nExclusion Criteria:\n\n* Patients with systemic diseases, severe medical complications or allergic history concerning methacrylates.\n* Lack of patient compliance, pregnancy, rampant caries, heavy smoking or xerostomia.\n* Evidence of parafunctional habits and TMJ disorders.\n* Class V lesions in molars.\n* Non-carious cervical lesions.\n* Deep carious defects (close to pulp, less than 1 mm distance).\n* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.\n* Endodontically treated teeth.\n* Tooth hypersensitivity.\n* Possible prosthodontic restoration of teeth.\n* Heavy occlusion and occlusal contacts or history of bruxism.\n* Severe periodontal affection.'}, 'identificationModule': {'nctId': 'NCT05509127', 'briefTitle': 'Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Cervical Restorations Performance Using Modified Universal Adhesive Compared to Conventional Universal Adhesive: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Modified Universal Adhesive'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carious cervical lesions treated with modified universal adhesive', 'description': 'Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of modified universal adhesive. The cavity is then restored with nano-filled resin composite.', 'interventionNames': ['Drug: Modified universal adhesive']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carious cervical lesions treated with conventional universal adhesive', 'description': 'Preparation of class V cavity with removal of caries and beveling of margins is done followed by total etching prior to application of conventional universal adhesive. The cavity is then restored with nano-filled resin composite.', 'interventionNames': ['Drug: Conventional universal adhesive']}], 'interventions': [{'name': 'Modified universal adhesive', 'type': 'DRUG', 'otherNames': ['3M ESPE™ Scotchbond Universal Plus Adhesive'], 'description': "Application of the modified universal adhesive is done according to manufacturer's instructions using a micro-brush. It is actively rubbed for 20 seconds, gently air-dried for 5 seconds then light cured for 20 seconds.", 'armGroupLabels': ['Carious cervical lesions treated with modified universal adhesive']}, {'name': 'Conventional universal adhesive', 'type': 'DRUG', 'otherNames': ['3M ESPE™ Single Bond Universal Adhesive'], 'description': 'Application of the conventional Single Bond Universal adhesive is done using a micro-brush followed by rubbing for 20 seconds, gentle air drying for 5 seconds then light curing for 20 seconds.', 'armGroupLabels': ['Carious cervical lesions treated with conventional universal adhesive']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry - Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Basma Gamal Dawoud', 'investigatorAffiliation': 'Cairo University'}}}}