Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT06509269
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoral Scanning v.s Desktop Scanning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-13', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-13', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of denture base', 'timeFrame': '"through study completion, an average of 1 year"', 'description': 'Measuring tool: Digital force meter, Measuring unit: Newton (N)'}, {'measure': 'Adaptation of denture base', 'timeFrame': '"through study completion, an average of 1 year"', 'description': 'Measuring tool: Geomagic Control X software, Measuring Unit: Millimeter (mm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraoral Scanning', 'CAD/CAM denture', 'Desktop Scanning'], 'conditions': ['Edentulous Jaw']}, 'referencesModule': {'references': [{'pmid': '36571837', 'type': 'BACKGROUND', 'citation': 'Osman RB, Alharbi NM. Influence of scan technology on the accuracy and speed of intraoral scanning systems for the edentulous maxilla: An in vitro study. J Prosthodont. 2023 Dec;32(9):821-828. doi: 10.1111/jopr.13633. Epub 2023 Jan 11.'}, {'pmid': '31153614', 'type': 'BACKGROUND', 'citation': 'Lo Russo L, Caradonna G, Troiano G, Salamini A, Guida L, Ciavarella D. Three-dimensional differences between intraoral scans and conventional impressions of edentulous jaws: A clinical study. J Prosthet Dent. 2020 Feb;123(2):264-268. doi: 10.1016/j.prosdent.2019.04.004. Epub 2019 May 29.'}, {'pmid': '33678434', 'type': 'RESULT', 'citation': "Manicone PF, De Angelis P, Rella E, Damis G, D'addona A. Patient preference and clinical working time between digital scanning and conventional impression making for implant-supported prostheses: A systematic review and meta-analysis. J Prosthet Dent. 2022 Oct;128(4):589-596. doi: 10.1016/j.prosdent.2020.11.042. Epub 2021 Mar 5."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.', 'detailedDescription': 'The use of intra oral scanners (IOS) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. The stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. The main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with well-developed ridge\n* Firm healthy mucosa\n* Free from any signs of inflammation\n\nExclusion Criteria:\n\n* Patients having flabby ridge\n* Decreased flow of saliva\n* Limited mouth opening'}, 'identificationModule': {'nctId': 'NCT06509269', 'briefTitle': 'Intraoral Scanning v.s Desktop Scanning', 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': 'Effect Of Intraoral Scanning Versus Desktop Scanning on The Retention Of Maxillary Denture Bases In Completely Edentulous Patients', 'orgStudyIdInfo': {'id': 'Digital scanning'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Desktop Scanning', 'description': 'Desktop scanning of Definitive Impression', 'interventionNames': ['Procedure: Desktop scanning']}, {'type': 'EXPERIMENTAL', 'label': 'IntraOral Scanning', 'description': 'Intraoral scanning of edentulous Jaw', 'interventionNames': ['Procedure: intraoral scanning']}], 'interventions': [{'name': 'intraoral scanning', 'type': 'PROCEDURE', 'description': 'Intraoral Scanning of edentulous Jaw', 'armGroupLabels': ['IntraOral Scanning']}, {'name': 'Desktop scanning', 'type': 'PROCEDURE', 'description': 'Desktop scanning of definitive impression', 'armGroupLabels': ['Desktop Scanning']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Shorook', 'country': 'Egypt', 'facility': 'British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ramy K Elashmawy, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British University In Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass.Lecturer', 'investigatorFullName': 'Ramy khalifa ashmawy', 'investigatorAffiliation': 'British University In Egypt'}}}}