Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03221803
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction assessed using questionnaire', 'timeFrame': '9 months', 'description': 'Questionnaire for patient satisfaction'}], 'secondaryOutcomes': [{'measure': 'bone height', 'timeFrame': '9 months', 'description': 'radio graphically by digora'}, {'measure': 'bone density', 'timeFrame': '9 months', 'description': 'radio graphically by digora'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Satisfaction', 'Bone Changes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study aimed to answer a clinical question whether In a patient with bilateral distal extension area, would the metal framework partial denture with OT vertical attachment versus partial denture with OT CAP attachment result in better patient satisfaction?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients age ranged between 35-45years old.\n* All patients have Kennedy class I partially edentulous mandibular arch in which the last remaining teeth were the second premolars bilaterally.\n* The abutment teeth had an apparently good periodontal condition with no signs of mobility or inflammation with firm and healthy mucosa.\n* Edentulous ridge covered by health firm mucoperiosteum, without abnormal bony irregularity or severe lingual undercuts.\n* Patients with normal relationship of maxilla and mandible (Angle class I ridge classification) and sufficient inter-arch space (6mm) the size of the attachment\n* The opposing dentition is intact arch with no noticeable over eruption or tilting or restored with acceptable fixed restoration.\n* All patients are free from neurological, muscular disorders and tempro-mandibular joint disorders.\n* Only patients who can be easily motivated to achieve and maintain good oral\n\nExclusion Criteria:\n\n* Patient with limited skills\n* Un co-operative patients.\n* patient with bad oral hygiene'}, 'identificationModule': {'nctId': 'NCT03221803', 'briefTitle': 'Patient Satisfaction and Bone Changes for OT Cap and OT Vertical Attachment', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Patient Satisfaction and Bone Changes in Bilateral Distal Extension Case Using OT Cap Versus OT Vertical Attachment "Randomized Clinical Trial"', 'orgStudyIdInfo': {'id': 'OT Cap_OT Vertical'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OT Vertical attachment', 'description': 'The attachment consists of a male part that is in the form of a steady with a central hole. This part is attached to the abutments .the female component is a white standard retentive clip engaging the outer walls of a steady male. It is incorporated in the partial denture together with a castable balancing pin that fits into the central hole of the steady male and aids in centering the prosthesis during the final stage of insertion; thereby ensuring a longer life to the retentive clips.', 'interventionNames': ['Other: OT Vertical attachment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OT Cap attachment', 'description': 'Beveled castable bar with micro-size sphere located in first molar region, and attached to the distal surface of the waxed crowns to be cast as one piece, Nylone caps of standard retention for micro size sphere this nylon caps fit onto their spheres and located in metal housing at fitting surface on the denture and Positioning rings to maintain the space for nylon cap during construction of the partial denture metal framework.', 'interventionNames': ['Other: OT cap attachment']}], 'interventions': [{'name': 'OT Vertical attachment', 'type': 'OTHER', 'otherNames': ['Castable twin cylinder attachment'], 'description': 'new extra coronal castable attachment', 'armGroupLabels': ['OT Vertical attachment']}, {'name': 'OT cap attachment', 'type': 'OTHER', 'otherNames': ['extra coronal castable attachment'], 'description': 'standard extra coronal attachment', 'armGroupLabels': ['OT Cap attachment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Hassaan, PHD', 'role': 'CONTACT', 'email': 'ahmedhassan871983@gmail.com', 'phone': '01021722944'}, {'name': 'Yusr Mady', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at faculty of dentistry fayoum university', 'investigatorFullName': 'Ahmed Mohamed Ali Hassaan', 'investigatorAffiliation': 'Cairo University'}}}}