Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 11:50 AM
Study NCT ID:
NCT03006757
Status:
UNKNOWN
Last Update Posted:
2016-12-30
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic
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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-29', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2016-12-29', 'lastUpdatePostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic with titanium dioxide nanoparticles in maxillary single denture using i load star sensor', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .', 'detailedDescription': 'Bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .Determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. In addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system .\n\nTwenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the Removable Prosthodontics Department, Faculty of Oral and Dental Medicine, Cairo University.\n\nThe primary outcome is to measure the biting force of single maxillary complete denture by I Load star sensor .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space\n* edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship\n\nExclusion Criteria:\n\n* patients with bad habits\n* previous history of radiotherapy or chemotherapy'}, 'identificationModule': {'nctId': 'NCT03006757', 'briefTitle': 'Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Measurement of the Biting Force of Rabid Heat Cured Acrylic Resin Versus Modified Conventional Acrylic Resin With Titanium Dioxide Nanoparticles in Maxillary Single Dentures', 'orgStudyIdInfo': {'id': '900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Column titanium dioxide', 'description': 'patient take titanium dioxide denture participants will receive titanium dioxide denture ( made from conventional acrylic resin modified by titanium dioxide nanoparticles ) for 1 month in the initial phase of the trial.', 'interventionNames': ['Other: titanium dioxide denture base']}, {'type': 'EXPERIMENTAL', 'label': 'column placebo', 'description': 'patient will take denture with conventional acrylic ( 20 minutes cure ) for 1 month in the initial phase', 'interventionNames': ['Other: titanium dioxide denture base']}], 'interventions': [{'name': 'titanium dioxide denture base', 'type': 'OTHER', 'armGroupLabels': ['Column titanium dioxide', 'column placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Giza', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mahmoudd 002 radwan, bachelor', 'role': 'CONTACT', 'email': 'mahmoud_omega@yahoo.com', 'phone': '00201009714746', 'phoneExt': '002'}, {'name': 'emad 002 gamal, bachelor', 'role': 'CONTACT', 'email': 'mahmoud_omega@yahoo.com', 'phone': '01009714746', 'phoneExt': '002'}], 'facility': 'Mahmoud Adly', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'mahmoud adly radwan, master', 'role': 'CONTACT', 'email': 'mahmoud_omega@yahoo.com', 'phone': '00201009714746', 'phoneExt': 'cairo'}, {'name': 'mahmoud adly radwan, bachelor', 'role': 'CONTACT', 'email': 'mahmoud_omega@yahoo.com', 'phone': '00201009714746', 'phoneExt': 'cairo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'emad gamal ismail', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'principal invistigator', 'investigatorFullName': 'emad gamal ismail', 'investigatorAffiliation': 'Cairo University'}}}}