Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT04152460
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2019-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-14', 'studyFirstSubmitDate': '2019-11-03', 'studyFirstSubmitQcDate': '2019-11-03', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Integrity', 'timeFrame': '1 year', 'description': 'Modified US Public Health Service Criteria (USPHS)'}], 'secondaryOutcomes': [{'measure': 'Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )', 'timeFrame': '1 year', 'description': 'Modified US Public Health Service Criteria (USPHS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bulk-fill resin Composite', 'Thermo-Viscous resin Composite', 'Proximal Compound Cavities'], 'conditions': ['Clinical Significance of Thermo-Viscous Composite']}, 'descriptionModule': {'briefSummary': 'A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.', 'detailedDescription': 'Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable .\n\nPreheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage.\n\nA new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency.\n\nPreheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties .\n\nFollow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aging more than 18 years .\n* Patients with a high level of oral hygiene.\n* Patients having at least 12 posterior teeth in occlusion.\n* Patients with good likelihood of recall availability.\n\nTooth Inclusion :\n\n* Permanent premolars and molars.\n* Moderate to deep compound class II cavities.\n* well formed fully erupted .\n* Vital with positive reaction to cold and hot stimulus.\n\nExclusion Criteria:\n\n* Participants with general systematic illness.\n* Pregnant or lactating females.\n* Concomitant participation in another research study.\n* Inability to comply with study procedures.\n* Heavy Bruxism habits.\n* Patients receiving Orthodontic treatment.\n* last experience with allergic reactions against any component of used materials .\n\nTooth exclusion :\n\n* Non vital teeth.\n* Secondary carious lesions.\n* Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.'}, 'identificationModule': {'nctId': 'NCT04152460', 'briefTitle': 'Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'PHD-CU-2019-10-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thermo-Viscous preheated bulk fill resin composite', 'description': 'Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)', 'interventionNames': ['Device: Viscalor Bulk (VOCO,Cuxhaven)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional Bulk Fill resin Composite', 'description': 'GrandioSo X-tra (Voco,Cuxhaven', 'interventionNames': ['Other: Grandioso x-tra']}], 'interventions': [{'name': 'Viscalor Bulk (VOCO,Cuxhaven)', 'type': 'DEVICE', 'description': 'Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)', 'armGroupLabels': ['Thermo-Viscous preheated bulk fill resin composite']}, {'name': 'Grandioso x-tra', 'type': 'OTHER', 'description': 'Nanohybrid Bulk Resin Composite', 'armGroupLabels': ['Conventional Bulk Fill resin Composite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'state': 'Mokattam', 'country': 'Egypt', 'facility': 'Yasmin', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Olfat Hasanen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Yasmin Atef Ahmed Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}