Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06296459
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2024-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A 2 arm study using two methods of imaging in a participant'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dimensional Change in augmentation at 8mm', 'timeFrame': 'Baseline immediately postoperatively and at 6 months', 'description': 'Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 8mm from alveolar crest.'}, {'measure': 'Dimensional Change in augmentation at 10mm', 'timeFrame': 'Baseline immediately postoperatively and at 6 months', 'description': 'Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 10 mm from alveolar crest.'}, {'measure': 'Dimensional Change in augmentation at 12mm', 'timeFrame': 'Baseline immediately postoperatively and at 6 months', 'description': 'Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 12 mm from alveolar crest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cone beam computed tomography', 'Sinus anatomy', 'Dental implant placement'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'A closed sinus augmentation is performed for dental implant placement.', 'detailedDescription': 'Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement.\n2. At least 5mm of native bone below the maxillary sinus.\n3. Nonsmokers.\n4. If diabetic, current HbA1C \\<7.0 (less than or equal to 7.0)\n\nExclusion Criteria:\n\n1. Maxillary sinus disease.\n2. Pregnancy or attempting to become pregnant.\n3. Diseases that affect bone metabolism.\n4. Use of medications known to affect bone metabolism.\n5. Tobacco use.\n6. Alcoholism or recreational drug use.\n7. Diabetic with HbA1C \\>7.0 (above 7.0)'}, 'identificationModule': {'nctId': 'NCT06296459', 'briefTitle': 'Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation', 'orgStudyIdInfo': {'id': '20220556HU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low volume CBCT', 'description': 'Radiographic low volume cone beam computed tomography used to plan implant placement', 'interventionNames': ['Other: 3D R100 scanner']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard periapical radiographs', 'description': 'Standard radiography used to plan implant placement', 'interventionNames': ['Other: Conventional Radiograph']}], 'interventions': [{'name': '3D R100 scanner', 'type': 'OTHER', 'otherNames': ['Veraviewpocs'], 'description': 'A cone beam computed tomography used for planning of implant surgery', 'armGroupLabels': ['Low volume CBCT']}, {'name': 'Conventional Radiograph', 'type': 'OTHER', 'otherNames': ['Standard Periapical Radiograph'], 'description': 'Imaging used as standard of care to plan for implant surgery', 'armGroupLabels': ['Standard periapical radiographs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Charles Powell, DDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After study completion in a peer review journal', 'ipdSharing': 'YES', 'description': 'All deidentified participant data will be shared with colleagues'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}