Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT01493232
Status:
UNKNOWN
Last Update Posted:
2011-12-20
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-09-17', 'releaseDate': '2013-07-06'}], 'estimatedResultsFirstSubmitDate': '2013-07-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-17', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-14', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' Satisfaction", 'timeFrame': '1 year', 'description': 'method of measurement is Questionair'}], 'secondaryOutcomes': [{'measure': "Patients' Dissatisfaction", 'timeFrame': '1 year', 'description': 'method of measurement Examination and Questionair'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lingualized occlusion', 'Complete denture occlusion', 'Fully bilateral balanced occlusion', 'Patient satisfaction of complete denture'], 'conditions': ['Edentulous']}, 'referencesModule': {'references': [{'pmid': '24138344', 'type': 'DERIVED', 'citation': 'Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.'}], 'seeAlsoLinks': [{'url': 'http://researches.mui.ac.ir', 'label': 'Department of Research and Technology, Medical University of Isfahan, Iran'}]}, 'descriptionModule': {'briefSummary': "In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected. For each participant, it will be made 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participants can leave it. Each set will be inserted for 1month in 5 participant randomly. The participants will be examined in two stages, after a day and after a week. At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors. Then the second and third denture will be inserted simultaneously."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* edentulous patients\n* at least 3 month ago the latest teeth was extracted\n* ideal jaw relation\n* signing the informed consent\n\nExclusion Criteria:\n\n* uncontrolled systemic disease\n* mentally problem\n* dissatisfaction for keeping on the study'}, 'identificationModule': {'nctId': 'NCT01493232', 'briefTitle': 'Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture', 'orgStudyIdInfo': {'id': '190052'}, 'secondaryIdInfos': [{'id': 'IRCT201110097749N1', 'type': 'OTHER_GRANT', 'domain': 'Medical Uuniversity of Isfehan 1244003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denture, edentulous patient, treatment', 'description': 'Dentures with different type of occlusion', 'interventionNames': ['Other: buccalized occlusion']}, {'type': 'EXPERIMENTAL', 'label': 'Denture, Edentulous patient, treatment', 'description': 'Dentures with different type of occlusion', 'interventionNames': ['Other: buccalized occlusion']}], 'interventions': [{'name': 'buccalized occlusion', 'type': 'OTHER', 'otherNames': ['K06.9', 'Disorder of gingiva and edentulous alveolar ridge, unspecified'], 'description': 'Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country. In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.', 'armGroupLabels': ['Denture, Edentulous patient, treatment', 'Denture, edentulous patient, treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81745-319', 'city': 'Isfahan', 'state': 'Isfahan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Mohammad Javad Shirani, Under graduated Student', 'role': 'CONTACT', 'email': 'javaad.sh_f@yahoo.com', 'phone': '00989356039479'}, {'name': 'Mohammad Javad Shirani, Under graduated Student', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'centralContacts': [{'name': 'Mohammad Javad Shirani, Under graduated Student', 'role': 'CONTACT', 'email': 'javaad.sh_f@yahoo.com', 'phone': '00989356039479'}], 'overallOfficials': [{'name': 'Ramin Mosharraf, Prosthodontics Specialist', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Isfahan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mohammad Javad Shirani, Isfahan University of Medical Sciences, Faculty of dentistry,Dnt.mui.ac.ir, Perincipal investigator, Dental student.', 'investigatorFullName': 'Mohammad Javad Shirani', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-07-06', 'type': 'RELEASE'}, {'date': '2013-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohammad Javad Shirani, Mohammad Javad Shirani, Isfahan University of Medical Sciences, Faculty of dentistry,Dnt.mui.ac.ir, Perincipal investigator, Dental student., Isfahan University of Medical Sciences'}}}}