Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT07120256
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2025-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Attachment Systems in Mandibular Single Implant Overdenture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcome assessor of 1ry outcome, statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'baseline, 1month, 6 months, 1 and 3 years', 'description': 'Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q. likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)'}], 'secondaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'baseline, 1 month, 3 and 6 months', 'description': 'Measuring device: Force meter Measuring unit: Newton/cm2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Satisfaction', 'Edentulous Mandible']}, 'descriptionModule': {'briefSummary': 'to compare locator attachment to ball attachment in retaining mandibular single implant overdenture in terms of patient satisfaction and retention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completely edentulous patient\n2. Patients having enough bone for an implant length of at least 10 mm\n3. Sufficient inter-arch space to accommodate the denture \\& the attachment\n4. No apparent Skeletal mal-relation\n5. No intraoral soft and hard tissue pathology\n6. No systemic condition that contraindicate implant placement\n\nExclusion Criteria:\n\n1. Drug or alcohol abuse\n2. Smokers\n3. A health condition precluding surgery,\n4. Logistic or physical reasons that could affect follow-up,\n5. Psychiatric problems\n6. Medically compromised patients \\& those with neuromascular disorders\n7. Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.'}, 'identificationModule': {'nctId': 'NCT07120256', 'briefTitle': 'Different Attachment Systems in Mandibular Single Implant Overdenture', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Different Attachment Systems in Mandibular Single Implant Overdenture', 'orgStudyIdInfo': {'id': 'single implant overdenture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ball and socket attachment', 'description': 'mandibular single implant overdenture retained by ball and socket attachment', 'interventionNames': ['Other: ball and socket attachment']}, {'type': 'EXPERIMENTAL', 'label': 'locator attachment', 'description': 'mandibular single implant overdenture retained by locator attachment', 'interventionNames': ['Other: locator attachment']}], 'interventions': [{'name': 'locator attachment', 'type': 'OTHER', 'description': 'mandibular single implant overdenture retained by locator attachment', 'armGroupLabels': ['locator attachment']}, {'name': 'ball and socket attachment', 'type': 'OTHER', 'description': 'mandibular single implant overdenture retained by ball and socket attachment', 'armGroupLabels': ['ball and socket attachment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'state': 'Manial', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Arwa Sedky Abd El-lateef', 'investigatorAffiliation': 'Cairo University'}}}}