Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT06204692
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Guided Versus Freehand Dental Implant Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'marginal bone loss', 'timeFrame': '6 months postoperative', 'description': 'Cone Beam Computed Tomography'}], 'secondaryOutcomes': [{'measure': 'post-surgical pain and swelling', 'timeFrame': '7 days prior to implant placement', 'description': 'Visual Analog Scale (10 represent maximum pain , 0 represent no pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual planning;', 'computer guided implants;', 'freehand implant;', 'dental implant'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': "This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.", 'detailedDescription': 'Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least two implants to be restored with a single prosthesis, were recruited one after the other. Patients were randomly assigned to two groups in a parallel group trial design. : Group I: consisted of 6 patients where computer guided dental implant placement and Group II: included six people who had dental implants placed manually. A temporary prosthesis was inserted into the implants right away, and four to six months later, a permanent prosthesis took its place.\n\nImplant failures, marginal bone loss, number of therapy sessions, length of treatment, post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve problems, and patient satisfaction were among the outcome variables evaluated by a blinded, independent assessor. Patients were tracked for a full year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* totally edentulous in one or both arches,\n* with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.\n* patients between the ages of 35 and 65 who could give informed permission,\n* Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.\n\nExclusion Criteria:\n\n* Patients who have received radiation therapy to the head and neck region within the year prior to implantation,\n* those who are receiving intravenous amino bisphosphonates,\n* those who have untreated periodontitis,\n* those with uncontrolled diabetes,\n* pregnant women, or nursing mothers are among the general contraindications to implant surgery.'}, 'identificationModule': {'nctId': 'NCT06204692', 'acronym': 'dental implant', 'briefTitle': 'Computer Guided Versus Freehand Dental Implant Surgery', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Computer Guided Versus Freehand Dental Implant Surgery: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'RECO6U/29-2022'}, 'secondaryIdInfos': [{'id': 'October6U', 'type': 'OTHER', 'domain': 'October 6 University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Computer Guided Dental Implant Surgery.', 'description': 'Computer Guided Dental Implant Surgery', 'interventionNames': ['Procedure: dental implant']}], 'interventions': [{'name': 'dental implant', 'type': 'PROCEDURE', 'description': 'consisted of 6 patients where computer guided dental implant placement', 'armGroupLabels': ['Computer Guided Dental Implant Surgery.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12566', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'nermine Ramadan Mahmoud', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor, faculty of Dentistry, October 6 University', 'investigatorFullName': 'Nermine Ramadan Mahmoud', 'investigatorAffiliation': 'October 6 University'}}}}