Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06934551
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008439', 'term': 'Maxillary Diseases'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '3 months', 'description': 'will be assessed by 5-point Likert scale capturing various degrees of opinion from strongly disagree, disagree, neutral agree, to strongly agree. data will be collected and sent to statistician for the analysis required in mean difference and standard deviation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Diseases']}, 'descriptionModule': {'briefSummary': 'randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques', 'detailedDescription': 'randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with hemi maxillectomy\n* Sufficient number of natural teeth not less than 5 teeth\n* Age between 30 and 60 years\n* Intact soft palate\n\nExclusion Criteria\n\n* Cognitive impairment\n* Heavy smokers\n* Patients exposed to radiotherapy'}, 'identificationModule': {'nctId': 'NCT06934551', 'briefTitle': 'Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients Rehabilitated With Laser CAD CAM & Conventionally Constructed Obturators', 'orgStudyIdInfo': {'id': '1224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAD CA laser polished obturator', 'description': 'the intervention obturator is to be made digitally with CAD CAM technology then laser polished', 'interventionNames': ['Device: obturator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventionally constructed obturator', 'description': 'the control group will receive conventionally constructed obturator', 'interventionNames': ['Device: obturator']}], 'interventions': [{'name': 'obturator', 'type': 'DEVICE', 'otherNames': ['conventionally constructed obturator'], 'description': 'conventionally constructed and polished obturator', 'armGroupLabels': ['CAD CA laser polished obturator', 'conventionally constructed obturator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'nehal elsherif', 'role': 'CONTACT', 'email': 'nehal.elsherif@dentistry.cu.edu.eg', 'phone': '01001982995'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Nehal Abdelrahim Amin Elsherif', 'investigatorAffiliation': 'Cairo University'}}}}