Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-27 @ 2:00 AM
Study NCT ID:
NCT05910333
Status:
UNKNOWN
Last Update Posted:
2023-10-23
First Post:
2023-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four Locator Attachment Mandibular Overdentures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Crestal bone loss around implants', 'timeFrame': '10 years', 'description': 'amount of bone loss which appears on a periapical radiograph.'}], 'primaryOutcomes': [{'measure': 'Posterior mandibular ridge resorption (PMandRR)', 'timeFrame': '10 years retrospective study', 'description': 'The amount of PMandRR will be assessed using posterior area index on a panoramic x-ray which use specific landmarkds.'}], 'secondaryOutcomes': [{'measure': 'Anterior maxillary ridge resorption (AMaxRR)', 'timeFrame': '10 years', 'description': 'The amount of PMandRR will be assessed using anterior area index on a panoramic x-ray, which use specific landmarks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Resorption']}, 'descriptionModule': {'briefSummary': '. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.', 'detailedDescription': 'Numerous studies confirm the successful use of implants to retain prostheses in the edentulous atrophic mandible. It has been recommended by some authors that clinicians should use 3 or 4 implants in situations that require increased retention, such as high muscle attachment or prominent mylohyoid ridge. LOCATOR attachment as a retentive component has several advantages over other systems, Such as: dual retention through both external and internal mating surfaces, a self-aligning feature which is helpful in guiding patients when placing their denture. There is little information on the degree of crestal bone loss around 4 inter-foraminal implant-retained mandibular overdentures (OVDs) and the amount of bone remodelling on the anterior maxilla and posterior mandibule on long-term function, particularly with different distributions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '10 patients in each group. total number of patients 20.', 'genderDescription': 'above 60', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with 4 implants in the inter-foraminal region.\n* Patients treated by staff and students in the Master's program in Prosthodontics Department according to the following criteria:\n* Edentulous maxilla and mandible for at least 1 year.\n* Problems with retention and stability of the mandibular denture.\n* Mandibular bone height between 15 and 25 mm.\n\nExclusion Criteria:\n\n* Patients with relative contraindications, such as\n* A history of para functional habits.\n* Smokers more than 10 cigarettes per day.\n* alcoholism.\n* Patients with a history of radiation therapy in the head and neck region . • Patients within intravenous administrated bisphosphonates., chemotherapy, and mental disorders that could jeopardies their co-operation."}, 'identificationModule': {'nctId': 'NCT05910333', 'briefTitle': 'Four Locator Attachment Mandibular Overdentures', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Ten Years Retrospective Study of 4 LOCATOR Attachment of Mandibular Implant Retained Overdenture With 2 Different Distributions.', 'orgStudyIdInfo': {'id': 'A0103023RP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quadrilateral distribution group', 'description': 'Patients with quadrilateral distribution of implants', 'interventionNames': ['Other: observation']}, {'label': 'Linear distribution group', 'description': 'Patients with lineardistribution of implants', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'To compare the effect of the mandibular implant retained OVD using quadrilateral distribution (QD) versus linear distribution (LD) on posterior mandibular ridge resorption (PMandRR), anterior maxillary ridge resorption (AMaxRR), and changes to the crestal bone level around implants after 10 years of function.', 'armGroupLabels': ['Linear distribution group', 'Quadrilateral distribution group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Multiple Locations', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed E Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '+201061314522'}, {'name': 'Salah A. Hegazy, PhD', 'role': 'CONTACT', 'email': 'salahhegazy2003@yahoo.com', 'phone': '+01227690809'}], 'facility': 'Mohammed El Sawy'}], 'centralContacts': [{'name': 'Mohammed E Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '+201061314522'}, {'name': 'Salah A. Hegazy, PhD', 'role': 'CONTACT', 'email': 'salahhegazy@yahoo.com', 'phone': '+01227690209'}], 'overallOfficials': [{'name': 'Mohammed E Sawy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'just by contacting the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Elsawy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer, Department of prosthodontics, principle investigator', 'investigatorFullName': 'Mohamed Elsawy', 'investigatorAffiliation': 'Mansoura University'}}}}