Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:19 AM
Study NCT ID:
NCT05899712
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2023-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: Alveolar Bone Height Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2023-06-03', 'studyFirstSubmitQcDate': '2023-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar Bone Height Changes', 'timeFrame': 'one year', 'description': 'Alveolar bone height changes of abutment teeth and residual ridge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denture, Partial, Removable']}, 'descriptionModule': {'briefSummary': "This clinical study compares between digital and conventional altered cast techniques using digitally constructed frameworks in removable partial dentures' construction regarding their effect on bone height changes around abutment teeth and in residual ridge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. All patients having completely edentulous maxilla and class I Kennedy mandible.\n2. Sufficient (not less than 15 mm) restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.\n3. All patients are of angel's class I maxillo-mandibular relationships\n4. Abutment teeth must meet certain requirements :\n\nA. Abutment teeth should be healthy with good periodontal and bone support. B. should not show advanced destructions. C. should not show a pronounced degree of mobility or advanced gingival recession.\n\nD. Crown Root Ratio for an abutment is 1:2\n\nExclusion Criteria:\n\n1. Sever undercuts or concavities on the buccal or lingual sides of the ridge.\n2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.\n3. History of radiotherapy in the head and neck region.\n4. Crown Root Ratio for an abutment is 1:1."}, 'identificationModule': {'nctId': 'NCT05899712', 'briefTitle': 'Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: Alveolar Bone Height Changes', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Digital Versus Conventional Altered Cast Techniques For Constructing Mandibular Distal Extension Removable Partial Dentures Using Digitally Fabricated Frameworks: A Clinical Comparative Parallel Study of Alveolar Bone Height Changes', 'orgStudyIdInfo': {'id': 'A0203023RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Digitally obtained altered cast for construction of mandibular free end saddle removable partial denture', 'interventionNames': ['Other: Removable Partial Denture Construction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Conventionally obtained altered cast for construction of mandibular free end saddle removable partial denture', 'interventionNames': ['Other: Removable Partial Denture Construction']}], 'interventions': [{'name': 'Removable Partial Denture Construction', 'type': 'OTHER', 'description': 'Construction of class I Removable partial denture by digital workflow', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlyia', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}