Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT06120868
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'a randomized controlled split-mouth study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success of the restoration', 'timeFrame': 'up to 12 months', 'description': 'Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class II Dental Caries']}, 'referencesModule': {'references': [{'pmid': '38655672', 'type': 'DERIVED', 'citation': 'Ellithy MS, Abdelrahman MH, Afifi RR. Comparative clinical evaluation between self-adhesive and conventional bulk-fill composites in class II cavities: A 1-year randomized controlled clinical study. J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in need of restorative treatment on at least two class II Cavities in premolars or molars.\n* Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I).\n* Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™).\n* Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact.\n* Absence of parafunctional habits.\n* Good general health\n\nExclusion Criteria:\n\n* Serious medical disorders\n* Clinical signs of bruxism, traumatic malocclusion\n* Pregnant or breast feeding at the time of restoration placement\n* Intolerance or allergy toward the applied restorative materials'}, 'identificationModule': {'nctId': 'NCT06120868', 'briefTitle': 'Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites (a Randomized Controlled Clinical Study)', 'orgStudyIdInfo': {'id': '7/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surefil one Self-adhesive bulk fill restorative (SABF)', 'interventionNames': ['Other: Surefil one®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Filtek One Bulk Fill (FOBF)', 'interventionNames': ['Other: Filtek One']}], 'interventions': [{'name': 'Surefil one®', 'type': 'OTHER', 'description': 'For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.', 'armGroupLabels': ['Surefil one Self-adhesive bulk fill restorative (SABF)']}, {'name': 'Filtek One', 'type': 'OTHER', 'description': 'Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.', 'armGroupLabels': ['Filtek One Bulk Fill (FOBF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21512', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mohamed S Ellithy, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Rania R Afifi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Mohamed H Hussein, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}