Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 10:49 PM
Study NCT ID:
NCT06109792
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Group I: Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.\n\nGroup II: Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.\n\nGroup III: Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.\n\nGroup IV: Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'One year', 'description': 'patient satisfaction was recorded using score system on a scale from 0 to 100'}, {'measure': 'oral health related quality of life', 'timeFrame': 'one year', 'description': 'Oral health related quality of life was evaluated by using scoring system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prosthesis User']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate patient satisfaction and OHRQL using two pick-up methods for locator retained mandibular overdenture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All selected patients will have two implants placed in the mandibular interforaminal region.\n\n 2\\. All selected patients have a healthy mucosa and have no clinical complications.\n\n 3\\. All patients are cooperative and approve of the proposed treatment protocol\n\nExclusion Criteria:\n\n* 1\\. Patients who refuse to participate in the study 2.Patients who need implant placement as a result of previous implant failure'}, 'identificationModule': {'nctId': 'NCT06109792', 'briefTitle': 'Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Patient Satisfaction and Oral Health-related Quality of Life (OHRQL) For Two Pick-up Techniques of the Locator Retentive Caps for Two Implant-supported Mandibular Overdentures: A Crossover Study', 'orgStudyIdInfo': {'id': 'A0108023RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Group I', 'description': 'Ten overdentures with locator retentive caps and blue inserts were picked up by the indirect method.', 'interventionNames': ['Procedure: implant supported mandibular overdenture']}, {'type': 'ACTIVE_COMPARATOR', 'label': '• Group II', 'description': 'Ten overdentures with locator retentive caps and pink inserts were picked up by the indirect method.', 'interventionNames': ['Procedure: implant supported mandibular overdenture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'Ten overdentures with locator retentive caps and blue inserts were picked up by the direct method.', 'interventionNames': ['Procedure: implant supported mandibular overdenture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group IV', 'description': 'Ten overdentures with locator retentive caps and pink inserts were picked up by the direct method.', 'interventionNames': ['Procedure: implant supported mandibular overdenture']}], 'interventions': [{'name': 'implant supported mandibular overdenture', 'type': 'PROCEDURE', 'description': 'In this crossover study, the patients received overdentures with two successive different pick-up techniques for the locator retentive caps; each technique was evaluated for patient satisfaction with blue and pink retentive inserts.', 'armGroupLabels': ['Group III', 'Group IV', '• Group I', '• Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O.Box:35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University ,Faculty of dentistry', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}