Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT05949151
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}, {'id': 'D004576', 'term': 'Electromyography'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009213', 'term': 'Myography'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "the investigator didn't know which patients belonged to which group"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-07-14', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusal equilibrations', 'timeFrame': 'Day 1 , one month and 3 month', 'description': 'assessed by Occlusense device'}, {'measure': 'Muscle activities', 'timeFrame': 'Day 1 , one month and 3 month', 'description': 'assessed by Electromyograph (EMG) device'}], 'secondaryOutcomes': [{'measure': 'oral health-related quality of life (OHRQoL)', 'timeFrame': 'Day 1, one month and 3 month', 'description': 'Oral Health-related Quality of Life questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant supported overdenture', 'muscle activity'], 'conditions': ['Occlusion']}, 'descriptionModule': {'briefSummary': '22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.\n\nThe patients were randomly categorized into two groups according to the final restoration.', 'detailedDescription': 'Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.\n\nOcclusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* edentulous mandible with well-developed alveolar ridge\n* free from temporomandibular joint disorder\n* free from any chronic diseases.\n\nExclusion Criteria:\n\n* smoker\n* patients having systemically immunosuppressive diseases\n* patients receiving radiotherapy.'}, 'identificationModule': {'nctId': 'NCT05949151', 'briefTitle': 'Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture', 'orgStudyIdInfo': {'id': '14312012023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I', 'description': 'Patients received a complete removable mandibular implant supported overdenture', 'interventionNames': ['Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)', 'Device: Occlusense (Bausch GmbH & Co. KG)', 'Device: electromyography (EMG) (Nemus II)".', 'Other: oral health-related quality of life (OHRQoL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Patients received implant supported fixed bridge', 'interventionNames': ['Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)', 'Device: Occlusense (Bausch GmbH & Co. KG)', 'Device: electromyography (EMG) (Nemus II)".', 'Other: oral health-related quality of life (OHRQoL)']}], 'interventions': [{'name': 'dental implants (K1 line conical connection double thread, OXY, Italy)', 'type': 'PROCEDURE', 'description': 'Six dental implants inserted on the edentulous mandible', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'Occlusense (Bausch GmbH & Co. KG)', 'type': 'DEVICE', 'description': 'sensor used to evaluate the equilibration of occlusal forces.', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'electromyography (EMG) (Nemus II)".', 'type': 'DEVICE', 'otherNames': ['Assessment of Muscle Activity by electromyography (EMG) (Nemus II)'], 'description': 'EMG recordings were accomplished by a computer electromyography-based data acquisition system', 'armGroupLabels': ['Group I', 'Group II']}, {'name': 'oral health-related quality of life (OHRQoL)', 'type': 'OTHER', 'description': 'Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic.', 'armGroupLabels': ['Group I', 'Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12622', 'city': 'Cairo', 'state': 'Dokki', 'country': 'Egypt', 'facility': 'National Research Centre', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Asmaa Elboraey, Ass.Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Centre, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asmaa Nabil Elboraey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Asmaa Nabil Elboraey', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}