Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 4:36 AM
Study NCT ID:
NCT06900868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-22', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-03-22', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent caries', 'timeFrame': 'T0: 1 Week Baseline T1: 6 Months T2: 12 Months', 'description': '* 0: no evidence of caries continuous along the margin using periapical radiograph.\n* 1: caries evident continuous with the margin of restoration'}], 'secondaryOutcomes': [{'measure': 'Fracture of Restoration', 'timeFrame': 'T0: 1 Week Baseline T1: 6 Months T2: 12 Months', 'description': '* 1: Restoration is intact and fully retained.\n* 2:Restoration is partially retained with some portion of the restoration still intact.\n* 3:Restoration is completely missing'}, {'measure': 'Post- operative sensitivity', 'timeFrame': 'T0: 1 Week Baseline T1: 6 Months T2: 12 Months', 'description': '* 1: Absent\n* 2: Present'}, {'measure': 'Bleeding on Probing', 'timeFrame': 'T0: 1 Week Baseline T1: 6 Months T2: 12 Months', 'description': '* 0 :Healthy gums\n* 1 :Bleeding on probing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep margin elevation'], 'conditions': ['DME', 'Dental Caries', 'Dental', 'Deep Margin Elevation']}, 'referencesModule': {'references': [{'pmid': '38003997', 'type': 'BACKGROUND', 'citation': 'Felemban MF, Khattak O, Alsharari T, Alzahrani AH, Ganji KK, Iqbal A. Relationship between Deep Marginal Elevation and Periodontal Parameters: A Systematic Review. Medicina (Kaunas). 2023 Nov 3;59(11):1948. doi: 10.3390/medicina59111948.'}, {'pmid': '35656656', 'type': 'BACKGROUND', 'citation': 'Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.'}]}, 'descriptionModule': {'briefSummary': 'Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients (20-50)\n* Good oral hygiene (plaque index 0 or 1 )\n* Patient approving to participate in the study\n* Absence of parafunctional habits and/or bruxism\n* No sign of irreversible pulpitis\n* No periapical radiolucency\n* Deep subgingival margin\n* Molars class II with subgingival margin\n\nExclusion Criteria:\n\n* • Patients with known allergic or adverse reaction to the tested materials.\n\n * Systematic disease that may affect participation.\n * Xerostomic patients.\n * Bad oral hygiene (plaque index 2 or 3 )\n * Heavy smokers\n * Patients undergoing or will start orthodontic treatment\n * Patients with removable prothesis'}, 'identificationModule': {'nctId': 'NCT06900868', 'briefTitle': 'The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Deep marginal elevation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'arm', 'description': 'Beautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material', 'interventionNames': ['Other: Assigned Interventions']}], 'interventions': [{'name': 'Assigned Interventions', 'type': 'OTHER', 'description': 'SDR Smart dentine replacement material nonbioactive', 'armGroupLabels': ['arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED A Yakop, BDS', 'role': 'CONTACT', 'email': 'Ahmed.yakop66@Gmail.com', 'phone': '00201555134512'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'AHMED AYMAN ESMAIL MAHMOUD', 'investigatorAffiliation': 'Future University in Egypt'}}}}