Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT04548258
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bony changes assessment', 'timeFrame': '12 months', 'description': 'assessment of bone height changes around implants using digital periapical paralling imaging technique and the unit will be meagured in mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Resorption']}, 'descriptionModule': {'briefSummary': 'comparing bony changes around implants that will be joined by ametal framework either with electric weiling or with the conventional casting metal', 'detailedDescription': 'joining multiple implants together in the edentulous arches is considered agood solution, using the conventional casting technique has many disadvantages due to lab errors and time and cost consuming on ,the other hand the study aims to owercome these disadvantages using electric welding metal framework.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 30 to 65 years old.\n* Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.\n* The patients must be completely edentulous.\n* The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.\n* Patients with good oral hygiene.\n* Complete denture wearer.\n* Adequate inter arch space for screw retained prosthesis.\n* Absence of any intra-oral pathological condition.\n\nExclusion Criteria:\n\nPatients with recent extraction(less than three months).\n\n* Patients with inflamed ridge or candida infection.\n* Patients with flappyridge.\n* Parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT04548258', 'briefTitle': 'Bone Changes Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Cast One', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Bone Changes Assessment in Screw-Retained Maxillary Implant Supported Complete Denture With Electric Welded Metal Framework Versus Cast One (Randomized Control,Split Mouth Trial)', 'orgStudyIdInfo': {'id': '6420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electric welded metal framework', 'description': 'using electric welding device to intraorally join metal framework where the study aim to save time and cost and eliminate lab errors', 'interventionNames': ['Device: electric intraoral weilding']}, {'type': 'EXPERIMENTAL', 'label': 'conventional cast metal technique', 'description': 'using the conventional casting technique to join metal framework and compare it with the electric welding technique', 'interventionNames': ['Device: casting']}], 'interventions': [{'name': 'electric intraoral weilding', 'type': 'DEVICE', 'description': 'weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally', 'armGroupLabels': ['electric welded metal framework']}, {'name': 'casting', 'type': 'DEVICE', 'description': 'casting metal framework', 'armGroupLabels': ['conventional cast metal technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'faculty of dentistry cairo dentistry', 'role': 'CONTACT'}, {'name': 'cairo university faculty of dentistry', 'role': 'CONTACT'}], 'facility': 'Cairo University ,Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'faculty of dentistry cairo university', 'role': 'CONTACT', 'email': 'dentmail@dentistry.cu.edu.eg', 'phone': '0235676105', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Shaimaa Magdy Abd Elhakm Mohmed', 'investigatorAffiliation': 'Cairo University'}}}}