Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
Study NCT ID:
NCT06628492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Guided Fabricated From Two Different Printing Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'linear deviation of inserted implant', 'timeFrame': '1 month', 'description': 'coronal and apical deviation of inserted implant from virtually planned one in millimeter.'}, {'measure': 'angular deviation of inserted implant', 'timeFrame': '1 month', 'description': 'angular deviation of inserted implant from virtually planned one in angles.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Partial-edentulism']}, 'descriptionModule': {'briefSummary': 'implant will be inserted in patients with kennedy class 3 or 4 partially edentulous mandible .the implants will be inserted using teeth supported surgical guide fabricated from two different materials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with skeletal Angle´s class I maxilla-mandibular relationship,\n2. adequate inter-arch distance, have Kennedy class 3 or 4 partially edentulous mandible of more than 2 teeth missed and will be applied for the treatment of tooth loss and requiring fixed prosthodontic rehabilitation\n3. normal Physical and psychological status to tolerate conventional implant procedures,\n4. Their residual ridge had sufficient bone volume for implant installation and was covered by firm mucoperiosteum.\n\nExclusion Criteria:\n\n1. Smokers.\n2. Patients undergoing chemotherapy or radiotherapy and immunocompromised patients.\n3. Patients with, systemic disease that might complicate post-operative healing or contribute to bone resorption, e.g uncontrolled diabetes, psychological disorders, or alcohol, tobacco, or drug abuse\n4. parafunctional habits, poor oral hygiene, limited mouth opening, severe alveolar bone deficiencies,'}, 'identificationModule': {'nctId': 'NCT06628492', 'briefTitle': 'Surgical Guided Fabricated From Two Different Printing Materials', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Comparative Assessment for the Positional Accuracy of Dental Implants Inserted by Computerized Surgical Guides Fabricated From Different Printing Materials', 'orgStudyIdInfo': {'id': '802/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A implant inserted by stainless steel surgical guide', 'interventionNames': ['Device: stainless steel printed surgical guide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B implant inserted by resin surgical guide', 'interventionNames': ['Device: resin printed surgical guide']}], 'interventions': [{'name': 'stainless steel printed surgical guide', 'type': 'DEVICE', 'description': 'the patient will wear the stainless steel surgical guide for the insertion of one implant', 'armGroupLabels': ['group A implant inserted by stainless steel surgical guide']}, {'name': 'resin printed surgical guide', 'type': 'DEVICE', 'description': 'the patient will wear the resin surgical guide for insertion of adjacent another implant implant', 'armGroupLabels': ['group B implant inserted by resin surgical guide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed m hebeshi, Phd', 'role': 'CONTACT', 'email': 'ahmed_hebeshi@dent.auez.edu.eg', 'phone': '00201282531256'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}