Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:15 AM
Study NCT ID:
NCT07410468
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The functional properties of the examined restorations', 'timeFrame': '1 year', 'description': 'All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Functional properties:\n\n(F1) Fracture of material and retention. (F2) Marginal adaptation. (F3) Proximal contact point. (F4) Form and contour. (F5) Occlusion and wear.\n\nEach evaluated property was scored according to the FDI criteria using the following clinical scores:\n\nScore 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), score 3: Clinically satisfactory (CS), score 4: Clinically unsatisfactory (CU), score 5: Clinically poor (PO).'}, {'measure': 'The biological properties of the examined restorations', 'timeFrame': '1 year', 'description': 'All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the revised FDI evaluation criteria and scoring system, which indicates: Biological properties (B1) Caries at restoration margins. (B2) Dental hard tissue defects at the restoration margin. (B3) Postoperative hypersensitivity and pulpal status.\n\nEach evaluated property was scored according to the FDI criteria using the following clinical scores:\n\nScore 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).'}, {'measure': 'The aesthetic properties of the examined restorations', 'timeFrame': '1 year', 'description': 'All restorations were assessed clinically at 1 week (baseline) and subsequently at 3, 6, 9, and 12 months, following the FDI evaluation criteria and scoring system, which indicates: Aesthetic properties:\n\n(A1) Surface luster and surface texture. (A2) Marginal staining. (A3) Color match.\n\nEach evaluated property was scored according to the FDI criteria using the following clinical scores:\n\nScore 1: Clinically excellent/very good (VG), Score 2: Clinically good (CG), Score 3: Clinically satisfactory (CS), Score 4: Clinically unsatisfactory (CU), Score 5: Clinically poor (PO).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class II Dental Restorations']}, 'descriptionModule': {'briefSummary': 'This clinical trial aimed to compare the 1-year clinical performance of a self-cure bulk fill (Stela Capsules), a dual-cure bulk fill (Fill-Up), and a light-cure bulk fill (Tetric N-ceram bulk fill) in class II dental composite restorations', 'detailedDescription': 'A total of 60 direct class II restorations were divided into three groups: Group I (n=20): were restored with self-cure bulk-fill (Stela capsules) with Stela primer; Group II (n=20): were restored with dual-cure bulk-fill (Fill-up) with ParaBond adhesive system; Group III (n=20): were restored with light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive. Each material was applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The presence of proximal caries on posterior teeth in a digital x-ray with a score of 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).\n* The antagonist and the adjacent tooth make contact.\n* The teeth should have no signs of pulpitis.\n* Patients with no periodontal disease\n* No major systemic disorders or allergies\n\nExclusion Criteria:\n\n\\- Extensive cavitated lesions, medical compromise, and traumatic malocclusion, bruxism, or parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT07410468', 'briefTitle': 'Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations.', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Clinical Performance of an Innovative Self-cure Bulk-Fill Composite Compared to Dual-Cure and Light-Cure Bulk-Fill Composite in Posterior Restorations (A Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': '9264203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group II: dual-cure bulk-fill (Fill-up) with ParaBond adhesive system', 'interventionNames': ['Other: Group II (n=20): were restored with dual-cure bulk-fill.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III: light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive.', 'interventionNames': ['Other: Group III (n=20): were restored with light-cure bulk-fill.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I: self-cure bulk-fill (Stela capsules) with Stela primer', 'interventionNames': ['Other: Group I (n=20): were restored with self-cure bulk-fill.']}], 'interventions': [{'name': 'Group I (n=20): were restored with self-cure bulk-fill.', 'type': 'OTHER', 'description': 'A total of 60 direct class II restorations were divided into three groups: Group I (n=20): were restored with self-cure bulk-fill (Stela capsules) with Stela primer applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \\< 0.05.', 'armGroupLabels': ['Group I: self-cure bulk-fill (Stela capsules) with Stela primer']}, {'name': 'Group II (n=20): were restored with dual-cure bulk-fill.', 'type': 'OTHER', 'description': 'A total of 60 direct class II restorations were divided into three groups: Group II (n=20): were restored with dual-cure bulk-fill (Fill-up) with ParaBond adhesive system applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \\< 0.05.', 'armGroupLabels': ['Group II: dual-cure bulk-fill (Fill-up) with ParaBond adhesive system']}, {'name': 'Group III (n=20): were restored with light-cure bulk-fill.', 'type': 'OTHER', 'description': 'A total of 60 direct class II restorations were divided into three groups: Group III (n=20): were restored with light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive. Each material was applied using its manufacturer-recommended self-etch adhesive protocol. All restorations were clinically evaluated after 1 week (baseline) and 3, 6, 9, and 12 months using the Revised FDI World Dental Federation (FDI) criteria. Comparisons of FDI criteria between the three groups and across different timepoints within each group were performed using Friedman and post-hoc Bonferroni tests. The significance level was set at p-value \\< 0.05.', 'armGroupLabels': ['Group III: light-cure bulk-fill (Tetric N-ceram bulk fill) with Tetric N-ceram universal adhesive.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marwan Abdelnaser', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Instructor of operative Dentistry', 'investigatorFullName': 'Marwan Abdelnaser', 'investigatorAffiliation': 'Alexandria University'}}}}